Kidney/Renal Cancer

Condition: Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07688187

Sponsor: PeptiDream Inc.

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• 1. Male or female participants aged ≥18 years. 2. Participants with confirmed diagnosis of ccRCC will be included based on the following characteristics:
• Histological confirmed locally advanced, unresectable, or metastatic ccRCC, after all available standard therapy.
• Presence of evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST) guideline (defined by RECIST v1.1). 3. Presence of positive tumor uptake 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1. 5. The participant's with adequate organ function 6. Life expectancy of at least 12 weeks as assessed by the Investigator.

Exclusion Criteria:

1. Concurrent serious (as determined by the Investigator), uncontrolled medical conditions, or life-threatening or other significant comorbid conditions.
2. Any chemotherapy, radiotherapy, immunotherapy, major surgery, biologic, investigational or hormonal therapy for treatment of solid tumors within 28 days.
3. Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy.
4. Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months.
5. Any previous CA9 targeting treatment.
6. Known hypersensitivity to the active substance or to any of the excipients of the PD-32766D and or T.
7. Clinically unstable CNS tumor at the time of screening.
8. History of bowel perforation or bowel infarction, history of active stomach or duodenum ulcer or fistula in the last 2 years, history of gastroesophageal reflux disease or enterocolitis Grade ≥3 according to NCI-CTCAE and/or known active gastrointestinal infection, any unresolved prior radiation-induced gastrointestinal injury.
9. Acute infection requiring IV antibiotics, antivirals, or antifungals within 14 days prior to the initiation of treatment (oral treatment are allowed).
10. Pregnant or breastfeeding women.
11. Known active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
12. Have been diagnosed with another primary malignancy.
13. Have significant, uncontrolled, or active cardiovascular disease
14. Bladder outflow obstruction or unmanageable urinary incontinence.
15. Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
16. Any major surgery within 12 weeks before enrolment.
17. History of psychiatric illness or social situations likely to interfere with ability to comply with protocol required assessment or give informed consent.

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Condition: Advanced RCC

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07611825

Sponsor: Jinling Hospital, China

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 90 Years
• Gender: All

Inclusion Criteria:

• Pathological Diagnosis and Subtype Specification Histologically confirmed metastatic renal cell carcinoma (mRCC) of either clear cell type or non-clear cell type, with non-clear cell histologies restricted to papillary, chromophobe, or unclassified subtypes. Sarcomatoid features are allowed. Other non-clear cell subtypes, including but not limited to collecting duct carcinoma and renal medullary carcinoma, are excluded. Based on the pathological subtype, enrolled patients will be assigned to two cohorts: the primary cohort consists of patients with histologically confirmed metastatic clear cell RCC, and the exploratory cohort consists of those with histologically confirmed metastatic non-clear cell RCC (subtypes limited to papillary, chromophobe, or unclassified).
• Immunotherapy Resistance Patients must have received at least two cycles of PD-1/PD-L1 ICI therapy and demonstrated disease progression either during treatment or within six months after the last dose. Progressive disease must be confirmed by the investigator according to RECIST 1.1 criteria, with additional radiographic confirmation performed within four weeks after the initial documented progression.
• Prior Treatment Lines and Sequence Restriction Patients must have received no more than two prior lines of systemic therapy, with no more than one line consisting of a PD-1/PD-L1 ICI. This PD-1/PD-L1 ICI based therapy may have been administered as first-line or second-line treatment for advanced or metastatic RCC, or as neoadjuvant or adjuvant therapy. Furthermore, this line of therapy must be the most recent prior treatment line, meaning that no other anticancer therapy has been administered following its completion.
• Lesion Requirement Patients must have at least one measurable lesion per RECIST v1.1, as assessed by the investigator or by local radiologic evaluation.
• Pre-treatment Tumor Biopsy Quality The pre-treatment tumor biopsy specimen must contain viable tumor tissue accounting for at least 75% of the total examined area.
• Prior Radiotherapy Washout Participants who have received palliative radiotherapy for non-central nervous system lesions must complete such therapy at least 2 weeks prior to the first dose of study treatment. Participants for whom the only measurable lesions reside within a previously irradiated field are eligible for enrollment, provided that such lesions have shown clear progression and remain accurately measurable.
• Recovery from Prior Treatment Toxicity All toxicities from prior anticancer therapies must have recovered to baseline or to Grade ≤1 according to the CTCAE version 5.0, with the exception of controllable AEs such as hypothyroidism that are clinically insignificant or remain stable under supportive care.
• General Baseline Status Patients must be ≥18 years of age, have an Eastern Cooperative Oncology Group (ECOG) performance status <2, an American Society of Anesthesiologists (ASA) score ≤2, and a life expectancy ≥6 months.
• Adequate Liver Function Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 × upper limit of normal (ULN), or ≤5 × ULN in patients with liver metastases. Total bilirubin ≤1.5 × ULN, except for patients with Gilbert's syndrome, in whom bilirubin ≤3.0 mg/dL is allowed.
• Adequate Renal Function Creatinine clearance ≥30 mL/min (Cockcroft-Gault formula) or serum creatinine ≤1.5 × ULN, and urine protein-to-creatinine ratio ≤1 mg/mg.
• Adequate Bone Marrow Function White blood cell count >2.0 × 10⁹/L, absolute neutrophil count >1.5 × 10⁹/L, platelet count >100 × 10⁹/L, lymphocyte count ≥0.3 × 10⁹/L, and hemoglobin ≥90 g/L, with no blood transfusion within 14 days prior to assessment.
• Viral Serology Patients must be negative for human immunodeficiency virus (HIV), negative for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with negative HBV DNA, and negative for hepatitis C antibody (HCV Ab), or positive with negative HCV RNA.
• Informed Consent Patients must provide written informed consent.
• Compliance Patients must be willing and able to adhere to the study protocol.

Exclusion Criteria:

• Recent Microbiota Interference Patients are excluded if they have received systemic antibiotics within 4 weeks prior to screening, or have received any live bacterial preparations or commercial prebiotics within 2 weeks prior to screening, or are currently using or plan to use probiotics, yogurt, or foods supplemented with bacteria during the treatment period.
• Immune-Related Severe Toxicity or Autoimmune Status Patients are excluded if they meet any of the following criteria:
• Have a history of permanent discontinuation of immunotherapy due to immune-mediated adverse events;
• Have active or known autoimmune disease, except for type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and vitiligo;
• Have an immunosuppressive status, defined as confirmed immunodeficiency, receipt of systemic corticosteroids at a dose equivalent to >10 mg of prednisone per day or other immunosuppressive agents (excluding inhaled or topical corticosteroids), or a history of active autoimmune disease requiring systemic therapy within the past 2 years.
• Prior Specific Immunotherapy or Excessive Therapy Patients are excluded if they have received prior treatment with a CTLA-4 ICI or more than two prior systemic therapy regimens.
• Gastrointestinal Risk Factors Patients are excluded if they have a history of inflammatory bowel disease (including Crohn's disease or ulcerative colitis); chronic severe diarrhea; or grade ≥3 immune-related colitis; or present with gastrointestinal metastatic lesions; or have undergone major abdominal surgery that may impair intestinal absorption or peristaltic function.
• Oral Administration Barrier Patients are excluded if they have dysphagia or are unable to take the required oral study medication.
• Rapid Tumor Progression Patients are excluded if they have rapidly progressive disease such that, in the opinion of the investigator, they cannot safely tolerate a 4-week washout period and a 2-week reconditioning period.
• Active Interstitial Lung Disease or Pneumonitis Patients with active interstitial lung disease or pneumonitis, or a history of either condition requiring systemic steroid therapy, are excluded.
• Uncontrolled Brain Metastases or Central Nervous System Disease Patients with known brain metastases, cranial epidural disease, or significant vasogenic edema are excluded unless they have received adequate radiotherapy or surgery and have been stable for at least 4 weeks prior to the first dose of study treatment.
• Severe Cardiac Disease Patients are excluded if they have a history of myocarditis or congestive heart failure (New York Heart Association [NYHA] class III-IV), unstable angina, uncontrolled severe arrhythmia, or myocardial infarction within 6 months prior to enrollment.
• Recent Other Antineoplastic Treatment Patients are excluded if they have received, prior to the first dose of study treatment:any small molecule kinase inhibitor within 2 weeks; cytotoxic agents, biologics, or other systemic anticancer therapies within 4 weeks; radiotherapy for bone metastases within 2 weeks, or any other radiotherapy within 4 weeks.
• Planned Other Antineoplastic Treatment Patients are excluded if they require any other systemic or local antineoplastic therapy during the study period, with the exception of bisphosphonates or denosumab for the management of bone metastases.
• Active Second Malignancy Patients are excluded if they have a second active malignancy diagnosed within the preceding 2 years, with the exception of indolent or early-stage tumors, including non-melanoma skin cancer and carcinoma in situ.
• Laboratory Abnormalities Patients are excluded if they meet any of the following criteria:
• White blood cell count <2.0 × 10⁹/L, absolute neutrophil count <1.5 × 10⁹/L, or platelet count <100 × 10⁹/L;
• AST/ALT >3 × ULN, or >5 × ULN in patients with liver metastases, or total bilirubin >1.5 × ULN (except for Gilbert's syndrome); ③Creatinine clearance <30 mL/min or serum creatinine >1.5 × ULN.
• Other Uncontrolled Comorbidities Patients are excluded if they have any of the following:
• Uncontrolled tumor-related pain, with painful lesions requiring palliative radiotherapy to be managed prior to enrollment;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage more frequently than once per month, the presence of an indwelling catheter such as a PleurX® device is permitted; ③Moderate to severe hepatic impairment, defined as Child-Pugh class B or C; ④Uncontrolled or symptomatic hypercalcemia.
• Other General Exclusions Patients are excluded if they meet any of the following criteria:
• Have received prior allogeneic stem cell transplantation or solid organ transplantation;
• Have active hepatitis B (HBV DNA positive), active hepatitis C (HCV RNA positive), or HIV infection;
• Have undergone major surgery within 4 weeks prior to study treatment;
• Have a history of allergy to food or antibiotics; ⑤Are pregnant, breastfeeding, or plan to conceive or father children during the study period (from pre-screening or screening visit until 120 days after the last dose); ⑥Require dialysis, have malabsorption syndrome, uncontrolled electrolyte disturbances, or require specific anticoagulants such as warfarin; ⑦Have any medical or psychological condition that may compromise safety or compliance.

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Condition: Advanced RCC

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07611825

Sponsor: Jinling Hospital, China

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 90 Years
• Gender: All

Inclusion Criteria:

• Pathological Diagnosis and Subtype Specification Histologically confirmed metastatic renal cell carcinoma (mRCC) of either clear cell type or non-clear cell type, with non-clear cell histologies restricted to papillary, chromophobe, or unclassified subtypes. Sarcomatoid features are allowed. Other non-clear cell subtypes, including but not limited to collecting duct carcinoma and renal medullary carcinoma, are excluded. Based on the pathological subtype, enrolled patients will be assigned to two cohorts: the primary cohort consists of patients with histologically confirmed metastatic clear cell RCC, and the exploratory cohort consists of those with histologically confirmed metastatic non-clear cell RCC (subtypes limited to papillary, chromophobe, or unclassified).
• Immunotherapy Resistance Patients must have received at least two cycles of PD-1/PD-L1 ICI therapy and demonstrated disease progression either during treatment or within six months after the last dose. Progressive disease must be confirmed by the investigator according to RECIST 1.1 criteria, with additional radiographic confirmation performed within four weeks after the initial documented progression.
• Prior Treatment Lines and Sequence Restriction Patients must have received no more than two prior lines of systemic therapy, with no more than one line consisting of a PD-1/PD-L1 ICI. This PD-1/PD-L1 ICI based therapy may have been administered as first-line or second-line treatment for advanced or metastatic RCC, or as neoadjuvant or adjuvant therapy. Furthermore, this line of therapy must be the most recent prior treatment line, meaning that no other anticancer therapy has been administered following its completion.
• Lesion Requirement Patients must have at least one measurable lesion per RECIST v1.1, as assessed by the investigator or by local radiologic evaluation.
• Pre-treatment Tumor Biopsy Quality The pre-treatment tumor biopsy specimen must contain viable tumor tissue accounting for at least 75% of the total examined area.
• Prior Radiotherapy Washout Participants who have received palliative radiotherapy for non-central nervous system lesions must complete such therapy at least 2 weeks prior to the first dose of study treatment. Participants for whom the only measurable lesions reside within a previously irradiated field are eligible for enrollment, provided that such lesions have shown clear progression and remain accurately measurable.
• Recovery from Prior Treatment Toxicity All toxicities from prior anticancer therapies must have recovered to baseline or to Grade ≤1 according to the CTCAE version 5.0, with the exception of controllable AEs such as hypothyroidism that are clinically insignificant or remain stable under supportive care.
• General Baseline Status Patients must be ≥18 years of age, have an Eastern Cooperative Oncology Group (ECOG) performance status <2, an American Society of Anesthesiologists (ASA) score ≤2, and a life expectancy ≥6 months.
• Adequate Liver Function Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 × upper limit of normal (ULN), or ≤5 × ULN in patients with liver metastases. Total bilirubin ≤1.5 × ULN, except for patients with Gilbert's syndrome, in whom bilirubin ≤3.0 mg/dL is allowed.
• Adequate Renal Function Creatinine clearance ≥30 mL/min (Cockcroft-Gault formula) or serum creatinine ≤1.5 × ULN, and urine protein-to-creatinine ratio ≤1 mg/mg.
• Adequate Bone Marrow Function White blood cell count >2.0 × 10⁹/L, absolute neutrophil count >1.5 × 10⁹/L, platelet count >100 × 10⁹/L, lymphocyte count ≥0.3 × 10⁹/L, and hemoglobin ≥90 g/L, with no blood transfusion within 14 days prior to assessment.
• Viral Serology Patients must be negative for human immunodeficiency virus (HIV), negative for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with negative HBV DNA, and negative for hepatitis C antibody (HCV Ab), or positive with negative HCV RNA.
• Informed Consent Patients must provide written informed consent.
• Compliance Patients must be willing and able to adhere to the study protocol.

Exclusion Criteria:

• Recent Microbiota Interference Patients are excluded if they have received systemic antibiotics within 4 weeks prior to screening, or have received any live bacterial preparations or commercial prebiotics within 2 weeks prior to screening, or are currently using or plan to use probiotics, yogurt, or foods supplemented with bacteria during the treatment period.
• Immune-Related Severe Toxicity or Autoimmune Status Patients are excluded if they meet any of the following criteria:
• Have a history of permanent discontinuation of immunotherapy due to immune-mediated adverse events;
• Have active or known autoimmune disease, except for type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and vitiligo;
• Have an immunosuppressive status, defined as confirmed immunodeficiency, receipt of systemic corticosteroids at a dose equivalent to >10 mg of prednisone per day or other immunosuppressive agents (excluding inhaled or topical corticosteroids), or a history of active autoimmune disease requiring systemic therapy within the past 2 years.
• Prior Specific Immunotherapy or Excessive Therapy Patients are excluded if they have received prior treatment with a CTLA-4 ICI or more than two prior systemic therapy regimens.
• Gastrointestinal Risk Factors Patients are excluded if they have a history of inflammatory bowel disease (including Crohn's disease or ulcerative colitis); chronic severe diarrhea; or grade ≥3 immune-related colitis; or present with gastrointestinal metastatic lesions; or have undergone major abdominal surgery that may impair intestinal absorption or peristaltic function.
• Oral Administration Barrier Patients are excluded if they have dysphagia or are unable to take the required oral study medication.
• Rapid Tumor Progression Patients are excluded if they have rapidly progressive disease such that, in the opinion of the investigator, they cannot safely tolerate a 4-week washout period and a 2-week reconditioning period.
• Active Interstitial Lung Disease or Pneumonitis Patients with active interstitial lung disease or pneumonitis, or a history of either condition requiring systemic steroid therapy, are excluded.
• Uncontrolled Brain Metastases or Central Nervous System Disease Patients with known brain metastases, cranial epidural disease, or significant vasogenic edema are excluded unless they have received adequate radiotherapy or surgery and have been stable for at least 4 weeks prior to the first dose of study treatment.
• Severe Cardiac Disease Patients are excluded if they have a history of myocarditis or congestive heart failure (New York Heart Association [NYHA] class III-IV), unstable angina, uncontrolled severe arrhythmia, or myocardial infarction within 6 months prior to enrollment.
• Recent Other Antineoplastic Treatment Patients are excluded if they have received, prior to the first dose of study treatment:any small molecule kinase inhibitor within 2 weeks; cytotoxic agents, biologics, or other systemic anticancer therapies within 4 weeks; radiotherapy for bone metastases within 2 weeks, or any other radiotherapy within 4 weeks.
• Planned Other Antineoplastic Treatment Patients are excluded if they require any other systemic or local antineoplastic therapy during the study period, with the exception of bisphosphonates or denosumab for the management of bone metastases.
• Active Second Malignancy Patients are excluded if they have a second active malignancy diagnosed within the preceding 2 years, with the exception of indolent or early-stage tumors, including non-melanoma skin cancer and carcinoma in situ.
• Laboratory Abnormalities Patients are excluded if they meet any of the following criteria:
• White blood cell count <2.0 × 10⁹/L, absolute neutrophil count <1.5 × 10⁹/L, or platelet count <100 × 10⁹/L;
• AST/ALT >3 × ULN, or >5 × ULN in patients with liver metastases, or total bilirubin >1.5 × ULN (except for Gilbert's syndrome); ③Creatinine clearance <30 mL/min or serum creatinine >1.5 × ULN.
• Other Uncontrolled Comorbidities Patients are excluded if they have any of the following:
• Uncontrolled tumor-related pain, with painful lesions requiring palliative radiotherapy to be managed prior to enrollment;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage more frequently than once per month, the presence of an indwelling catheter such as a PleurX® device is permitted; ③Moderate to severe hepatic impairment, defined as Child-Pugh class B or C; ④Uncontrolled or symptomatic hypercalcemia.
• Other General Exclusions Patients are excluded if they meet any of the following criteria:
• Have received prior allogeneic stem cell transplantation or solid organ transplantation;
• Have active hepatitis B (HBV DNA positive), active hepatitis C (HCV RNA positive), or HIV infection;
• Have undergone major surgery within 4 weeks prior to study treatment;
• Have a history of allergy to food or antibiotics; ⑤Are pregnant, breastfeeding, or plan to conceive or father children during the study period (from pre-screening or screening visit until 120 days after the last dose); ⑥Require dialysis, have malabsorption syndrome, uncontrolled electrolyte disturbances, or require specific anticoagulants such as warfarin; ⑦Have any medical or psychological condition that may compromise safety or compliance.

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Condition: Renal Cell Carcinoma (RCC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07087158

Sponsor: Imbioray (Hangzhou) Biomedicine Co., Ltd.

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. Male or female, age ≥ 18 years old
2. Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery.
3. Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma.
4. Expected survival period is at least 3 months.
5. ECOG performance status of 0 or 1, or KPS score of at least
6. Has measurable disease per RECIST 1.
7. Organ function should meet the following criteria:
8. Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelet (PLT) ≥90×10^9/L; Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days).
9. Albumin ≥ 30 g/L; Total bilirubin ≤1.5×ULN (for subjects with Gilbert's syndrome, it can be ≤3×ULN); ALT and AST ≤1.5×ULN (If liver metastasis is combined, ALT and AST≤3×ULN).
10. Creatinine (Cr) ≤1.5 × ULN; Creatinine clearance (Ccr) (to be calculated only when Cr > 1.5× ULN) > 50 ml/min (Cockcroft-Gault formula).
11. Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN.
12. Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures.

Exclusion Criteria:

1. Documented central nervous system metastases.
2. Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment.
3. Has received major surgery (grade 3 or 4 as defined in the Measures for the Administration of Clinical Application of Medical Technology) within 28 days before the first dose of study treatment and has not yet recovered from which; or any planned curative surgery for renal cell carcinoma during the study.
4. History of another malignancy within 5 years before the first dose of study treatment, except for Lung carcinoma in situ, low-risk early-stage prostate cancer, or cured basal-cell carcinoma, squamous-cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.
5. Clinically significant gastrointestinal abnormalities such as malabsorption syndrome, major gastric or small-bowel resection that may affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other conditions increasing the risk of perforation; or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the first dose of study treatment.
6. Systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents required within 2 weeks before the first dose or anticipated during study treatment, except for:
7. Topical, intranasal, or inhaled corticosteroids.
8. Corticosteroids as premedication for infusion-related or hypersensitivity reactions (e.g., premedication for CT imaging).
9. Replacement therapy such as levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency.
10. Low-dose corticosteroids for orthostatic hypotension.
11. Clinically significant cardiovascular or cerebrovascular disease documented by any of the following:
12. Ischemic stroke (excluding silent lacunar infarction) or severe thromboembolic event within 6 months before the first dose of study treatment.
13. Myocardial infarction, unstable angina, congestive heart failure, or clinically significant arrhythmia within 6 months before the first dose of study treatment.
14. New York Heart Association (NYHA) class ≥ II heart failure before the first dose of study treatment.
15. QTcF interval >450 ms (men) or >470 ms (women) before the first dose of study treatment.
16. Left-ventricular ejection fraction (LVEF) ≤50 % before the first dose of study treatment.
17. Prior organ transplant, except corneal transplant; prior allogeneic stem-cell transplant.
18. Hepatitis B surface antigen (HBsAg) positive with HBV DNA >500 IU/mL or >2,500 copies/mL, or hepatitis C antibody positive with detectable HCV RNA, or known HIV infection, or active tuberculosis.
19. Interstitial lung disease or non-infectious pneumonitis that is currently symptomatic or has previously required systemic corticosteroids, in the opinion of the investigator likely to interfere with toxicity assessment or management.
20. Any severe, progressive, or uncontrolled medical condition that, in the investigator's judgment, makes the subject unsuitable for the study, including but not limited to:
21. Infection requiring systemic therapy.
22. Symptomatic pleural, pericardial, or ascitic fluid requiring or having undergone drainage within 2 weeks before the first dose (minimal asymptomatic effusion, third-spacing due to hypoalbuminaemia, or cases where benefit outweighs risk may be allowed).
23. History of coagulopathy (e.g., deep-vein thrombosis) or severe bleeding diathesis; clinically significant bleeding event (e.g., gastrointestinal bleeding) within 1 month before the first dose.
24. History of severe psychiatric disorder.
25. Any other condition that, in the investigator's opinion, renders study participation riskier than beneficial.
26. Prior grade 3-4 immune-related adverse events that, in the investigator's judgment, should be excluded.
27. Severe allergic or hypersensitivity disorders, significant drug allergies (including to investigational agents), or known hypersensitivity to any component of the study drug, including severe reactions to monoclonal antibodies.
28. Participation in another clinical trial and receipt of an investigational agent within 28 days before the first dose of study treatment.
29. Clinically significant organ dysfunction or comorbidity likely to interfere with protocol adherence.
30. Live vaccine received within 30 days before the first dose, or planned during the study or within 1 month after the last dose.
31. Pregnant or breast-feeding women (women who agree to discontinue breast-feeding before signing informed consent may be enrolled).
32. Any other condition or circumstance that, in the investigator's opinion, unsuitable for participation.

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Condition: Kidney Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07672860

Sponsor: Jinling Hospital, China

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 75 Years
• Gender: All

Inclusion Criteria:

1. Patients must meet all of the following criteria to be eligible for inclusion in the study:
2. The patient has fully understood the study and has voluntarily signed the informed consent form (ICF);
3. Male or female patients aged 18 to 75 years, inclusive, at the time of signing the ICF;
4. Imaging diagnosis consistent with stage T1 renal tumor, as assessed by MRI or CT;
5. No definite collecting system invasion on preoperative MRI or CT assessment;
6. The patient is scheduled to undergo partial nephrectomy (PN) or renal tumor enucleation after clinical evaluation by the physician and full discussion with the patient;
7. Preoperative assessment indicates that main renal artery clamping with warm ischemia is planned;
8. The surgery will be performed by a surgeon with experience in at least 50 cases of PN or renal tumor enucleation, and renal artery clamping will be performed using standardized vascular clamp application;
9. Screening eGFR ≥30 mL/min/1.73 m², calculated using the CKD-EPI equation;
10. No history of allergy or intolerance to UDCA or other bile acid preparations, and no UDCA contraindications or biliary tract-related diseases that, in the investigator's judgment, would make the patient unsuitable for UDCA treatment;
11. The subject is willing and able to comply with the scheduled visits, treatment, laboratory tests, and other study-related procedures required by the protocol. 2.

Exclusion Criteria:

1. Patients meeting any of the following criteria will be excluded from the study:
2. Emergency surgery, defined as surgery required for medical reasons within 24 hours;
3. Patients who are considered preoperatively to have a significant risk of bleeding, or whose surgery is expected to require complex renal reconstruction, and who are judged by the investigator to be unsuitable for participation in this study;
4. Patients for whom non-standard ischemia techniques, such as selective/segmental arterial clamping or zero-ischemia techniques, are planned preoperatively;
5. Patients with a history of renal surgery on either kidney or previous kidney transplantation;
6. Solitary kidney;
7. History of major abdominal organ surgery within 1 year before surgery, which, in the investigator's judgment, may affect the conduct of the current surgery, safety assessment, or evaluation of study endpoints;
8. Active lesions or clinically significant imaging abnormalities in either kidney that may substantially affect renal function assessment or perioperative AKI risk evaluation, including but not limited to renal artery stenosis, polycystic kidney disease, chronic pyelonephritis, severe hydronephrosis, or renal atrophy;
9. Use of UDCA, chenodeoxycholic acid, bile acid sequestrants, or other drugs that may significantly affect bile acid metabolism within 1 month before screening;
10. Continuous or systemic use of nephrotoxic drugs for more than 1 week within 3 months before screening, including but not limited to nonsteroidal anti-inflammatory drugs and aminoglycoside antibiotics;
11. Continuous or systemic use of drugs that may significantly affect the gut microbiota or bile acid metabolism within 1 month before screening, including antibiotics, probiotics, high-dose glucocorticoids, immunosuppressants, potent laxatives, or antidiarrheal agents;
12. Participation in another interventional clinical study within 3 months before screening, or ongoing treatment with another investigational drug or device;
13. Uncontrolled active infection during the screening period, including but not limited to urinary tract infection, pulmonary infection, intra-abdominal infection, or systemic infection;
14. Uncontrolled blood pressure abnormalities during the screening period, including mean seated SBP ≥180 mmHg or DBP ≥110 mmHg; symptomatic hypotension, SBP <90 mmHg, or hypovolemia as judged by the investigator;
15. History of New York Heart Association (NYHA) class III-IV heart failure, or hospitalization due to heart failure/fluid retention within 6 months before screening;
16. Hepatic impairment, defined as meeting any of the following criteria: history of hepatic encephalopathy, history of esophagogastric varices, history of portocaval shunt surgery, Child-Pugh class C hepatic impairment, ALT or AST >3 × ULN, or total bilirubin >2 × ULN during the screening period;
17. Diseases or surgical history that may significantly affect the absorption, distribution, metabolism, or excretion of the study drug, including but not limited to:
18. history of active inflammatory bowel disease within the previous 6 months;
19. history of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, or bowel resection;
20. history of gastrointestinal ulcer and/or gastrointestinal or rectal bleeding within the previous 6 months;
21. history of pancreatic injury or pancreatitis within the previous 6 months; (17) Pregnant or breastfeeding women; (18) Women of childbearing potential who have a positive pregnancy test during the screening period, or who are unwilling to use effective contraception during the study; (19) Patients with a history of other malignancies are excluded, except for malignancies confirmed to have been cured or in remission for ≥5 years, radically resected basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ at any site； (20) Any other severe or uncontrolled medical disease, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation, affect subject compliance, or interfere with the interpretation of study results, including but not limited to organ failure, active or uncontrolled immunodeficiency disease, active or uncontrolled HBV/HCV/HIV infection, cognitive impairment, or severe psychiatric disorder.

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Condition: Renal Cell Carcinoma (RCC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07647744

Sponsor: Hrain Biotechnology Co., Ltd.

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum 70 Years
• Gender: All

Inclusion Criteria:

1. Age 18 to 70 years (inclusive), regardless of gender;
2. Life expectancy of more than 12 weeks;
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1;
4. Subjects with advanced/metastatic renal cell carcinoma (RCC):
5. Histologically confirmed clear cell renal cell carcinoma (ccRCC), with an International Metastatic RCC Database Consortium (IMDC) risk stratification of intermediate or high risk as evaluated by the investigator;
6. Has at least one measurable lesion according to RECIST 1.1;
7. Tumor tissue samples must test positive for CD70 expression via immunohistochemistry (IHC);
8. Must have received at least one prior line of systemic therapy (must include at least: (1) immuno-oncology (IO) combination therapy: concomitant targeting of PD-1 and CTLA-4, or (2) an immune checkpoint inhibitor (PD-1/PD-L1 inhibitor) combined with a VEGF/VEGFR-targeted agent);
9. Venous access required for apheresis can be established; hemoglobin ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5×10^9/L, and platelet count ≥ 100× 10^9/L, and the leukepheresis can be carried according to the judgement of investigators;
10. Hepatic, renal, cardiac, and pulmonary functions must meet the following criteria:
11. Creatinine clearance (CrCl) ≥ 50 mL/min (calculated by the Cockcroft-Gault formula);
12. Left ventricular ejection fraction (LVEF) > 50%;
13. Baseline peripheral oxygen saturation > 95%;
14. Total bilirubin ≤2 × upper limit of normal (ULN);
15. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;
16. Voluntary participation in the clinical study: Must understand and be informed about this study, voluntarily sign the Informed Consent Form (ICF), and be willing to complete all study procedures.

Exclusion Criteria:

1. Prior treatment with anti-CD70 targeted therapies;
2. Brain metastasis from renal cell carcinoma;
3. Concomitant with other uncontrolled malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery;
4. Any uncontrolled active infection, including but not limited to active tuberculosis; presence or suspicion of an uncontrolled infection, or an infection requiring systemic intravenous therapy within 14 days prior to enrollment (including fungal, bacterial, viral, or other infections);
5. Subjects who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, with peripheral blood HBV DNA titers above the lower limit of detection (LLOD) of the study site; those who are hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA positive; those who are human immunodeficiency virus (HIV) antibody positive; or those who test positive for syphilis;
6. Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within 6 months prior to screening, myocardial infarction within 6 months prior to screening, congestive heart failure (New York Heart Association [NYHA] classification ≥ III ), poorly controlled diabetes mellitus (glycated hemoglobin HbA1c > 8% at screening), poorly controlled severe arrhythmia, and hepatic, renal, or metabolic diseases by medication;
7. Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion (except for subjects of childbearing potential who are willing to use highly effective and reliable methods of contraception uninterruptedly for 1 year after the study treatment);
8. Prior treatment with CAR-T therapy or other genetically modified cell therapies prior to screening;
9. History of implantation of a cardiac pacemaker or deep brain stimulator;
10. Vaccination with live attenuated vaccines within 4 weeks prior to leukapheresis;
11. History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that resulted in end-organ damage, or required systemic immunosuppressive therapy or other systemic disease-controlling medications;
12. History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or psychiatric disorders; or known active CNS involvement or history thereof;
13. Subjects who are receiving systemic steroid therapy prior to screening, and who are judged by the investigator to require long-term use of systemic steroids during the study treatment period (excluding inhaled or topical steroids);
14. Presence of medical conditions that interfere with the ability to sign the written Informed Consent Form (ICF) or comply with study procedures; or those who are unwilling or unable to comply with study requirements;
15. History of severe immediate hypersensitivity reactions to any of the medications to be used in this study;
16. Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this study.

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Condition: Pheochromocytoma/Paraganglioma, Rhabdomyosarcoma, Paget Disease, Extramammary, Renal Angiomyolipoma, Perivascular Epithelioid Cell Tumor, Malignant, Sarcoma, Urachal Cancer, Neuroendocrine Cancer, Basal Cell Carcinomas, Sarcomatoid Carcinoma, Penile Cancer, Adrenal Cortical Cancer, Germ Cell Cancer Metastatic, Non-Clear Cell Renal Cell Carcinoma, Prostate Cancers, Clear Cell Renal Cancer, Urothelial Carcinoma, Kidney Cancer, Rare Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06683846

Sponsor: Fudan University

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Individuals able to understand and give written informed consent.
• Histologically or cytologically confirmed cancer of one of the following types: PAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant perivascular epithelioid cell tumor, Rhabdomyosarcom Other sarcoma rather than rhabdomyosarcom
• Stage IV disease
• Adequate performance status (ECOG 0-2)
• Expected survival ≥ 3 months.
• Measurable disease by CT or MRI, Or lesions with skin infiltration.
• Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
• Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
• Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN.
• Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.
• Ability to comply with research visit schedules and other protocol requirements.

Exclusion Criteria:

• With any severe and/or uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar [FBG] >10mmol/L); ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification); (3)active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE 2-level infection), including tuberculosis infection; A history of active tuberculosis; (4)Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage;
• With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU/ml or ≥10^4 copies/ml; HCV reference: HCV RNA≥2000 IU/ml or ≥10^4 copies/ml; after nucleoside analog antiviral therapy below the above standard, can be included; chronic hepatitis B virus carrier, HBV DNA<10^4 IU/ml, must be treated with antiviral drugs during the trial period to be eligible for enrollment);
• History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases;
• Active autoimmune disease requiring systemic treatment within the past two years, or subjects with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment of skin diseases (e.g. vitiligo, alopecia, psoriasis or eczema); autoimmune thyroiditis-induced hypothyroidism requiring stable dose replacement therapy with hormones; 13. Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies; individuals who are known to be allergic to the active ingredients or excipients of the study drug;
• Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry;
• Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study;
• History of severe allergies;
• At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy;
• History of substance abuse with an inability to abstain or a history of mental illness;
• Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study, or who, in the opinion of the investigator, have other reasons not to be enrolled; Subjects who have a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of seizure susceptibility;
• Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study (such as severe diabetes, thyroid disorders, and mental illness), or who have a serious and/or unstable medical, psychological, or other condition (including laboratory abnormalities) that would affect the subject's safety or the subject's ability to provide informed consent, or who have any condition that would affect the study protocol and follow-up plan, including psychological, familial, social, or geographic factors;

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Condition: Pheochromocytoma/Paraganglioma, Rhabdomyosarcoma, Paget Disease, Extramammary, Renal Angiomyolipoma, Perivascular Epithelioid Cell Tumor, Malignant, Sarcoma, Urachal Cancer, Neuroendocrine Cancer, Basal Cell Carcinomas, Sarcomatoid Carcinoma, Penile Cancer, Adrenal Cortical Cancer, Germ Cell Cancer Metastatic, Non-Clear Cell Renal Cell Carcinoma, Prostate Cancers, Clear Cell Renal Cancer, Urothelial Carcinoma, Kidney Cancer, Rare Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06683846

Sponsor: Fudan University

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Individuals able to understand and give written informed consent.
• Histologically or cytologically confirmed cancer of one of the following types: PAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant perivascular epithelioid cell tumor, Rhabdomyosarcom Other sarcoma rather than rhabdomyosarcom
• Stage IV disease
• Adequate performance status (ECOG 0-2)
• Expected survival ≥ 3 months.
• Measurable disease by CT or MRI, Or lesions with skin infiltration.
• Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
• Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
• Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN.
• Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.
• Ability to comply with research visit schedules and other protocol requirements.

Exclusion Criteria:

• With any severe and/or uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar [FBG] >10mmol/L); ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification); (3)active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE 2-level infection), including tuberculosis infection; A history of active tuberculosis; (4)Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage;
• With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU/ml or ≥10^4 copies/ml; HCV reference: HCV RNA≥2000 IU/ml or ≥10^4 copies/ml; after nucleoside analog antiviral therapy below the above standard, can be included; chronic hepatitis B virus carrier, HBV DNA<10^4 IU/ml, must be treated with antiviral drugs during the trial period to be eligible for enrollment);
• History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases;
• Active autoimmune disease requiring systemic treatment within the past two years, or subjects with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment of skin diseases (e.g. vitiligo, alopecia, psoriasis or eczema); autoimmune thyroiditis-induced hypothyroidism requiring stable dose replacement therapy with hormones; 13. Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies; individuals who are known to be allergic to the active ingredients or excipients of the study drug;
• Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry;
• Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study;
• History of severe allergies;
• At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy;
• History of substance abuse with an inability to abstain or a history of mental illness;
• Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study, or who, in the opinion of the investigator, have other reasons not to be enrolled; Subjects who have a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of seizure susceptibility;
• Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study (such as severe diabetes, thyroid disorders, and mental illness), or who have a serious and/or unstable medical, psychological, or other condition (including laboratory abnormalities) that would affect the subject's safety or the subject's ability to provide informed consent, or who have any condition that would affect the study protocol and follow-up plan, including psychological, familial, social, or geographic factors;

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Condition: Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04895709

Sponsor: Bristol-Myers Squibb

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• Radiographically documented progressive disease on or after the most recent therapy.
• Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
• Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant. Exclusion Criteria
• Women who are pregnant or breastfeeding.
• Primary central nervous system (CNS) malignancy.
• Untreated CNS metastases.
• Leptomeningeal metastases.
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
• Active, known, or suspected autoimmune disease.
• Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
• Prior organ or tissue allograft.
• Uncontrolled or significant cardiovascular disease.
• Major surgery within 4 weeks of study drug administration.
• History of or with active interstitial lung disease or pulmonary fibrosis.
• Other protocol-defined inclusion/

Exclusion Criteria:

• Women who are pregnant or breastfeeding.
• Primary central nervous system (CNS) malignancy.
• Untreated CNS metastases.
• Leptomeningeal metastases.
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
• Active, known, or suspected autoimmune disease.
• Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
• Prior organ or tissue allograft.
• Uncontrolled or significant cardiovascular disease.
• Major surgery within 4 weeks of study drug administration.
• History of or with active interstitial lung disease or pulmonary fibrosis.
• Other protocol-defined inclusion/exclusion criteria apply.

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Condition: Renal Cell Carcinoma (Kidney Cancer)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07321197

Sponsor: Tianjin Medical University Second Hospital

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Signed informed consent form.
• Age > 18 years.
• Candidate for radical nephrectomy with or without lymph node dissection.
• High-risk renal cell carcinoma defined as: At least ONE of: Clinical stage cT3-4 N0-1 M0 (AJCC 8th ed); OR radiologically visible lymph node >1cm; OR M1 disease rendered no evidence of disease (NED) after local therapy; OR radiologically determined rT4 stage. OR at least TWO of: Renal vein or inferior vena cava tumor thrombus; OR nuclear grade 3-4 or sarcomatoid differentiation or coagulative necrosis; OR tumor size >= 10cm; OR hematuria and/or local symptoms.
• Measurable disease as per RECIST v1.1.
• ECOG performance status of 0 or 1.
• Adequate bone marrow, renal, and hepatic function.
• For women and men of childbearing potential, agreement to use effective contraception during the study period.

Exclusion Criteria:

• Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC.
• Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival).
• Candidate for partial nephrectomy or ablation per multidisciplinary team assessment.
• Preoperative imaging indicates unresectable regional lymph nodes.
• renal tumors or known hereditary RCC syndrome.
• Diagnosis of any other active malignancy within the past 5 years.
• Active autoimmune disease or history of autoimmune disease.
• Use of immunosuppressive agents within 2 weeks prior to enrollment.
• Poorly controlled cardiac or clinical symptoms.
• Coagulopathy or bleeding tendency.
• Active gastrointestinal conditions with risk of bleeding or perforation.
• History of significant bleeding or thromboembolic events within specified timeframes.
• Active infection or unexplained fever >38.5°C.
• Abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks prior.
• History of pulmonary fibrosis, interstitial lung disease, or severely impaired pulmonary function.
• Known immunodeficiency or active hepatitis.
• Participation in another clinical trial within 1 month.
• Known history of drug abuse or alcohol addiction.
• Inability or unwillingness to bear the self-paid portion of examination and treatment costs.
• Any condition that, in the investigator's judgment, may compromise patient safety or study conduct.

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Condition: Renal Cell Carcinoma (RCC)

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT07657325

Sponsor: Tianjin Medical University Second Hospital

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Criteria: 1. There must be a histological diagnosis of renal cell carcinoma, with or without sarcomatoid features of clear cell components. 2. On the day of signing the informed consent form, both males and females must be at least 18 years old. 3. The participants provide written informed consent for the trial before enrollment. 4. Have high risk or M1 NED renal cell carcinoma as defined by the following pathological tumor-node-metastasis and Fuhrman grading status. 1. High risk RCC - pT4, Any Gr. N0, M0 - pT Any stage, Any Gr., N+, M0 2. M1 NED RCC (participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at the time of nephrectomy) 5. No previous systemic treatment for advanced RCC (except nephrectomy or pyelectomy) has been performed. 6. Radical nephrectomy (and complete resection of metastatic lesions in M1 NED participants) was performed with a negative surgical margin. 7. It must be evaluated by the investigator as tumor-free and verified by imaging such as CT or MRI. No suspicious brain metastases. 8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 9. Non-surgical sterilization or female participants of childbearing potential who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of non-surgical sterilization or childbearing age within 7 days prior to study enrollment; And must be non-lactation period; Non-surgical sterilization or male patients of childbearing age who consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the end of the study treatment period. 10. Vital organ function meets the following requirements (excluding use of any blood components and cell growth factors within 14 days) : normal bone marrow reserve function; Absolute neutrophil count (ANC)≥1500/µL, Platelets≥100 000/µL, Hemoglobin ≥5.6 mmol/L (9g/dL); Normal renal function or serum creatinine ≤1.5 mg/d and/or creatinine clearance ≥30 mL/min for participants with creatinine levels >1.5×institutional ULN; Normal liver function or Total bilirubin ≤1.5xULN, or direct bilirubin≤ULN for participants with total bilirubin levels >1.5×ULN; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.

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Condition: Metastatic Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07615348

Sponsor: Jinling Hospital, China

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• STEP0: At Treatment Initiation 1. Male or female subjects aged ≥ 18 years 2. Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV) 3. Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype 4. Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria 5. Karnofsky Performance Status (KPS) grade ≥ 70% 6. At least one measurable lesion on CT per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 7. At least one high-uptake target lesion on CD70-targeted immuno-PET/CT per Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) version 1.0 8. If CD70-negative lesions (visible on CT but lacking CD70 avidity on PET/CT) are present at baseline, they must meet ALL the following conditions: cannot be target lesions, cannot be located in major involved organs, must be ≤ 3 in number, and must account for ≤ 30% of the total tumor burden 9. Adequate organ and bone marrow function meeting all laboratory criteria:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥90 g/L
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × upper limit of normal(ULN) (or ≤ 5 × ULN if hepatic metastases are present). Total bilirubin ≤ 1.5 × ULN (≤ 3 mg/dL if Gilbert's syndrome)
• Serum creatinine ≤ 2.0 × ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the Cockcroft-Gault formula 10. Capacity to comprehend and comply with protocol requirements, with documented informed consent signed 11. Contraception agreement for sexually active fertile participants and partners to use medically accepted methods during the study and continue for 5 months after last treatment 12. Negative pregnancy status at screening for women of childbearing potential STEP1: At 12-Month Evaluation 1. Patient met all

Eligibility Criteria:

• outlined above 2. Patient must receive 12 months (±1m) of first line PD-1/PD-L1 ICI + VEGFR-TKI therapy, without permanent discontinuation of both agents due to unmanageable toxicity 3. Patient must have completed an CD70-targeted immuno-PET/CT scan at 12m (±1m) from start of initial therapy 4. Patients must meet one of the following criteria:
• Eligible for treatment discontinuation: For CD70-Positive Lesions: Sustained Disease Control (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]) on CT for ≥ 12 weeks per RECIST 1.1, AND achieved Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) on CD70 immuno-PET/CT per PERCIST 1.0 criteria; For CD70-Negative Lesions (If present at baseline): Must achieve a deep anatomical response, defined as Complete Response (CR) or Partial Response (PR) on CT, maintained for ≥ 12 weeks per RECIST 1.1
• Treatment continuation: not meeting criteria above

Exclusion Criteria:

1. STEP0: At Treatment Initiation
2. Prior systemic therapy for advanced RCC
3. Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
4. Karnofsky Performance Status (KPS) <70%
5. Inadequate organ and bone marrow function
6. Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) who are clinically stable without progression prior to treatment
7. Concurrent or prior invasive malignancies within the past 5 years, except adequately treated in situ/superficial cancers (e.g., non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix/breast)
8. Presence of uncontrolled major comorbidities or recent severe illnesses within 6 months, including but not limited to: uncontrolled hypertension, clinically significant cardiovascular disease, GI disorders with high risk of perforation/fistula, significant hematuria, hematemesis, hemoptysis, major bleeding history, severe active infections (including active HIV, HBV, or HCV), or severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis)
9. Life expectancy < 6 months
10. Known allergy or hypersensitivity to the CD70 imaging agent or any of its excipients
11. Severe hepatic or renal insufficiency, or inability to tolerate PET/CT examination
12. Medical/psychiatric/social conditions compromising protocol compliance
13. Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment STEP1: At 12-Month Evaluation
14. Failure to complete 12 months(±1m) of first-line PD-1/PD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or disease progression
15. Failure or inability to undergo CD70-targeted immuno-PET/CT scan at the 12-month evaluation timepoint
16. Unacceptable clinical deterioration or investigator discretion indicating that a treatment holiday is not in the best interest of the patient

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Condition: Unresectable or Metastatic Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07645690

Sponsor: Chinese PLA General Hospital

Phase: Early Phase 1

Eligibility:

• Age: minimum 18 Years maximum 75 Years
• Gender: All

Key Inclusion Criteria:

1. 1.Age 18-75 years (inclusive), any gender. 2.Confirmed by histopathology and/or cytology as unresectable or metastatic clear cell renal cell carcinoma; 3.Local progression or metastasis after receiving at least second line therapy [including at least one immune checkpoint inhibitor (ICI) and at least one vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI)]; 4.Willing to undergo tumor tissue sample collection or provide previous tumor tissue samples for CD70 expression level testing; 5.Positive CD70 expression by immunohistochemical (IHC) staining of tumor tissue (percentage of positive cells ≥ 10%); 6.At least one measurable lesion according to RECIST v1.1 criteria. 7.Karnofsky Performance Status (KPS) ≥ 70%. 8.Organ function must meet the following criteria:
2. Complete blood count (no G-CSF within 1 week prior to blood count testing. or no pegylated G-CSF within 2 weeks prior to blood count testing): Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L. platelet count (PLT) ≥ 100×10⁹/L. hemoglobin ≥ 80 g/L (excluding bone marrow suppression caused by lymphoma involvement of the bone marrow).
3. Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
4. Liver function: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3×ULN (if with liver metastasis, AST and ALT ≤ 5×ULN). total bilirubin ≤ 1.5×ULN.
5. Renal function: Serum creatinine ≤ 1.5×ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL/min.
6. Cardiac function: Left ventricular ejection fraction (LVEF) on echocardiography (ECHO) ≥ 50%, no pericardial effusion. no clinically significant abnormalities on 12-lead electrocardiogram (ECG).
7. Pulmonary function: End-blood oxygen saturation ≥ 92% while breathing room air without supplemental oxygen. no clinically significant pleural effusion. 9.Subjects and/or their partners of childbearing potential agree to use effective contraceptive measures throughout the entire treatment period and for 52 weeks after treatment, and during this period they must not donate eggs/sperm for assisted reproduction; Female participants of childbearing potential (women who have undergone sterilization surgery or have been postmenopausal for ≥12 months are not considered to have childbearing potential) must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period. 10.Willing to comply with all study procedures and voluntarily participate in this study and sign the informed consent form (ICF).

Key Exclusion Criteria:

1. Expected survival < 3 months.
2. Prior or concurrent active malignancy, with the exception of cured or recurrence-free for at least 3 years of cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery.
3. Prior use of CD70-targeted therapy.
4. Previous treatment with CAR-T or any other genetically engineered cell therapy.
5. History of central nervous system (CNS) disease or clinically significant CNS dysfunction, such as cerebral ischemia/hemorrhage, dementia, cerebellar disease, epilepsy, aphasia, dementia, etc.
6. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
7. Occurrence of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, or other clinically significant cardiac diseases within 12 months prior to screening.
8. Presence of CNS metastasis or symptoms of CNS metastasis.
9. Toxicities from prior therapy have not recovered to CTCAE grade ≤ 1, except for adverse events without safety risks (e.g., alopecia).
10. The anti-tumor therapy received is still within 5 half-lives prior to the planned ET-970 infusion.
11. Presence of uncontrolled active bacterial, fungal, or viral infections, or other infections deemed by the investigator as unsuitable for study participation.
12. Positive for human immunodeficiency virus (HIV) antibody, positive for Treponema pallidum antibody, positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with detectable peripheral blood HBV DNA, positive for hepatitis C virus (HCV) antibody with detectable HCV RNA; except for infections that can be prevented or controlled with medication as judged by the investigator.
13. History of other autoimmune diseases requiring immunosuppressive therapy.
14. Known severe allergy to the study drug or any of its components.
15. Pregnant or breastfeeding women.
16. Use of any live vaccines against infectious disease within 6 weeks before lymphodepletion conditioning.
17. Participation in another interventional clinical study and receipt of an active investigational drug within 3 months prior to signing the ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period.
18. Psychiatric disorders with depression or suicidal tendencies.
19. Presence of any other medical condition that may affect the evaluation of the safety and efficacy of the study drug.
20. Other factors due to which the patient is deemed unsuitable for participation by the investigator.

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Condition: Localized Clear Cell Renal Cell Carcinoma, Resectable Clear Cell Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07226544

Sponsor: City of Hope Medical Center

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Histologic confirmation of clear cell RCC
• High-risk disease defined as cT2G3-4N0M0, cT3GanyN0M0, cT4GanyN0M0, cTanyGanyN+M0 (Grade determined by biopsy)
• Candidate for partial or complete nephrectomy that extirpates all tumor tissue as part of treatment plan
• Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (no blood transfusions or growth factor therapy used within 7 days of the screening complete blood count [CBC])
• Platelet count ≥ 100 × 10^9/L (no blood transfusions or growth factor therapy used within 7 days of the screening CBC)
• Hemoglobin ≥ 9.0 g/dL (no blood transfusions or growth factor therapy used within 7 days of the screening CBC)
• Creatinine clearance (CrCL) ≥ 50 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by body surface area [BSA] is not required for eGFR)
• Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g
• Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤ 3 × ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastases, AST and ALT ≤ 5 × ULN
• Coagulation: Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose
• Female patients of childbearing age must have negative serum pregnancy test results before enrollment or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing
• Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab
• Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab
• Adults aged 18 years or older

Exclusion Criteria:

• Prior systemic anti-tumor treatment for RCC
• Major surgical procedures or serious trauma within 4 weeks prior to enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment
• History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:
• Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution
• Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
• Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone > 10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to enrollment, however the following will be allowed:
• Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted
• Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted
• History of major diseases before enrollment, specifically:
• Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)
• History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment
• History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollment
• Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment
• History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment
• Imaging during the screening period shows that the patient has metastatic disease
• Symptomatic central nervous system (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrolment, potential need for CNS radiation within the first cycle, or leptomeningeal disease
• Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrolment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted
• Severe infection within 4 weeks prior to enrolment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrolment (excluding antiviral therapy for hepatitis B or C)
• Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
• Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic
• History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
• Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
• Known history of human immunodeficiency virus (HIV) whose viral load is not controlled
• Current use of systemic corticosteroids (> 10 mg daily prednisone or equivalent)
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrolment. All patients with active hepatitis C (hepatitis C virus [HCV] antibody positive with HCV ribonucleic acid [RNA] levels above the lower limit of detection) are excluded
• Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies
• History or current evidence of any condition (medical [including adverse events from prior anticancer therapy, disorders secondary to tumor], surgical or psychiatric [including substance abuse]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and/or is not in the best interest of the patient to participate, in the opinion of the treating investigator
• Patient is breastfeeding or plans to breastfeed during the study
• History of severe immune-mediated adverse events from immunotherapy agents (i.e. PD1/PDL1/CTLA4 inhibitors), or immune-related ocular toxicity, pneumonitis, or cardiomyopathy of any grade

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Condition: Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07383441

Sponsor: SWOG Cancer Research Network

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Participants must have histologically confirmed renal cell carcinoma (RCC) with clear cell component that is advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC at the time of registration on study
• Participants must have measurable/evaluable disease by RECIST 1.1 criteria. Participants with only bone metastases or only pleural effusions are considered evaluable disease and are eligible
• Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated treatment during the first cycle of therapy
• Participants must not be currently enrolled or plan to participate in treatment studies while enrolled on this study
• Participants must not plan to take any over the counter probiotic supplements at time of study registration and while on protocol treatment
• NOTE: Vitamin and electrolyte or mineral supplements are permitted
• Participants must not have had prior systemic therapy for advanced or metastatic RCC or any treatment with immune based combination therapy
• NOTE: Participants can have prior neo/adjuvant treatment with an anti-PD-1, anti-PD-L1, and/or anti-CTLA-4 antibody or other therapies for any current or prior malignancy if > 12 months prior to registration
• Participants must not be receiving steroid replacement therapy for adrenal insufficiency greater than 50 mg daily of hydrocortisone or prednisone equivalent dose at the time of registration
• Participants must not require the use of systemic corticosteroids > 10 mg/day of prednisone or its equivalent for any reason other than replacement therapy for adrenal insufficiency
• Participants must not have received any systemic antibiotics within 7 days prior to registration
• NOTE: Uncontrolled infections must be completely resolved
• Participants must be ≥ 18 years old at the time of registration
• Participants must have a Zubrod performance status 0-2 within 28 days of registration
• Participants must be able to safely receive at least one of the standard of care regimens, per the current Food and Drug Administration (FDA)-approved package inserts, treating investigator's discretion, and institutional guidelines
• NOTE: Participants with favorable risk as defined by the International Metastatic RCC Database Consortium (IMDC) must plan to receive one of the TKI+ immunotherapy treatment combinations. They are not able to receive regimen 1 (ipilimumab + nivolumab) for this study
• Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
• Participants must have serum creatinine ≤ 2 x ULN (upper limit of normal). This specimen must have been drawn and processed within 28 days prior to registration
• Hemoglobin ≥ 8 g/dL (within 28 days prior to registration)
• Leukocytes ≥ 3 x 10^3/uL (within 28 days prior to registration)
• Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to registration)
• Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration)
• Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration) Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (< 5 x institutional ULN if liver metastases are present) (within 28 days prior to registration)
• Participants must have alkaline phosphate measured as a part of the liver function assessment within 28 days prior to registration
• Participants must have albumin corrected calcium measured within 28 days prior to registration
• Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration
• Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration
• Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration
• Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to registration
• Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
• Participants must not have any known history of an autoimmune disease that prohibits the use of immune checkpoint therapy
• Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
• Participants must be offered the opportunity to participate in specimen banking
• Participants who have the ability to complete questionnaires in English or Spanish must be offered the opportunity to participate in the patient-reported outcome study
• NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
• Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
• For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

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Condition: Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07510334

Sponsor: Mayo Clinic

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Age ≥ 18 years

Disease Characteristics:

• Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic [American Joint Committee on Cancer (AJCC) version 8 Stage IV] renal cell carcinoma (RCC) with a clear cell component, including all International Metastatic RCC Database Consortium (IMDC) risk categories (favorable, intermediate, and poor risk) allowed
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• NOTE: Liver lesions that have been previously embolized (bland embolization, chemo- or radio-embolization) or have undergone percutaneous thermoablation are not eligible as target lesions. Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
• Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained ≤ 15 days prior to registration)
• Platelet count ≥ 100,000/mm^3 (obtained ≤ 15 days prior to registration)
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
• Prothrombin time (PT)/international normalization ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 50 ml/min using the chronic kidney disease epidemiology (CKD-EPI) creatinine equation (per National Kidney Foundation) (obtained ≤ 15 days prior to registration)
• NOTE: See calculator at National Kidney Foundation website here: https://www.kidney.org/professionals/kdoqi/gfr_calculator
• Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
• Provide written informed consent
• Willingness to provide mandatory blood specimens for correlative research
• Willingness to provide mandatory tissue specimens for correlative research
• Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)

Exclusion Criteria:

• Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
• Prior treatment for advanced or metastatic RCC [American Joint Committee on Cancer (AJCC) Stage IV]
• History of portal vein thrombosis involving more than intrahepatic portal vein branches: thrombosis of the right or left portal vein branch or the bifurcation, partial or complete obstruction of the portal vein trunk
• NOTE: Level 0 or 1 tumor thrombus remain eligible; Level 2, 3, of 4 tumor thrombus related to the primary kidney tumor are ineligible
• Has received a live vaccine ≤ 30 days prior to registration
• NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are NOT allowed
• Any of the following prior therapies:
• Surgery ≤ 3 weeks prior to registration
• Chemotherapy ≤ 2 weeks prior to registration
• Radiation therapy ≤ 2 weeks prior to registration
• Therapy in the first-line setting for advanced or metastatic RCC
• Adjuvant immunotherapy during which or in the ≤ 6 months immediately following, relapse or disease progression has occurred
• New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias [atrial fibrillation or supraventricular tachycardia (SVT)]
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to:
• ongoing or active infection
• symptomatic congestive heart failure
• unstable angina pectoris
• cardiac arrhythmia
• dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
• or psychiatric illness/social situations that would limit compliance with study requirements
• Current immunodeficiency or immunosuppression and receiving systemic corticosteroids at > 10mg/day prednisone or equivalent ≤ 1 week prior to registration.
• NOTE: Inhaled steroids for pulmonary disease are permitted
• Known history of the following:
• Suspected active organ-threatening autoimmune disease including, but not limited to, inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis which can flare while receiving immune checkpoint inhibitor (ICI) treatment.
• NOTE: Patients with well-controlled or clinically inactive autoimmune diseases are eligible
• Non-infectious pneumonitis that required steroids, current pneumonitis, carcinomatous meningitis, or interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
• Known or ongoing illness or infection including:
• Any active Grade 3 or higher [per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0] viral, bacterial, or fungal infection ≤ 2 weeks of registration.
• Acute hepatitis B (HBV) or acute hepatitis C virus (HCV)
• NOTE: Patients with chronic HBV or HCV with adequate liver function per inclusion criteria are still eligible
• Patients known to be HIV positive and currently receiving antiretroviral therapy
• Known history of active tuberculosis (TB) (bacillus tuberculosis)
• Uncontrolled hypertension and/or diabetes
• Clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization ≤ 3 months prior to treatment)
• Receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any other investigational agent or therapy considered investigational (used for a non-Food and Drug Administration (FDA) approved indication and in the context of a research investigation)
• Known concurrent malignancy that is progressing or requires active treatment
• EXCEPTIONS: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-situ cervical cancer that has been treated with curative intent, prostate cancer confined to the prostate gland with Gleason score ≤ 6, as well as any cancer treated with curative intent or any prior cancer with a disease-free interval of ≥ 3 years
• History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

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Condition: Metastatic Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06783348

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 100 Years
• Gender: All

Inclusion Criteria:

• PRE-SCREENING
• Histologically proven ccRCC. Sarcomatoid component is allowed.
• Adult patients ≥18 years old.
• Has progressed on or after ≥1-line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-programmed death-1 (receptor) [PD-1]/programmed death-ligand 1 (PD-L1) therapy +/- ipilimumab and a VEGFR-TKI.
• Written pre-screening informed consent according to ICH/GCP and local regulations. SCREENING
• Patients with at least one PSMA-positive metastatic lesion, and no exclusionary PSMA-negative lesions, with positive lesions defined as those with a maximum standardized uptake value (SUVmax) greater than the mean standardized uptake value (SUVmean) of liver background.
• Measurable disease by RECIST 1.1 criteria.
• Patients with adequate blood tests (Absolute neutrophil count > 1.5 x 109/L, haemoglobin > 9.0 g/dL, platelet count > 100,000/µL, estimated glomerular filtration rate (GFR) ≥ 40 ml/min by CKD-EPI formula, total bilirubin ≤ 1.5 x ULN. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases).
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to registration. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test is to be reported within 7 days prior to the first dose of the study treatment. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.
• Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 14 weeks after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include:
• Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
• Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomized partner
• Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
• Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 3 months after the last study treatment.
• Before patient's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations. This includes consent to comply to recommended radioprotection precautions during study.

Exclusion Criteria:

• Patient with RCC in a single kidney.
• Patients with PSMA-negative lesions (defined as PSMA uptake equal to or lower than that of liver parenchyma) in any lymph node with a short axis of at least 15 mm, in any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short axis. Patients with any PSMA-negative metastatic lesion meeting these criteria are ineligible.
• Other malignancy that is expected to interfere with the treatment or results of this study, such as prostate cancer.
• Patient with active uncontrolled or symptomatic central nervous system (CNS metastases). Note: patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed.
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the in the trial.
• Known contraindication to imaging tracer or any product of contrast media.

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Condition: ccRCC, Complex Renal Cyst

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06949215

Sponsor: Peking Union Medical College Hospital

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. Age ≥ 18 y
2. Presence of complex renal cyst (Bosniak category II or higher)
3. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
4. Expected survival of at least 3 months
5. ECOG ≤ 2
6. Written informed consent provided for participation in the trial
7. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

1. On VEGF TKI treatment less than 1 week before 68Ga-NYM096 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NYM0
2. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM096 PET/CT is required.
3. Intercurrent medical condition that renders the patient ineligible for surgery.
4. Pregnancy or breastfeeding.
5. Severe claustrophobia.

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Condition: Active Surveillance, Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07023432

Sponsor: M.D. Anderson Cancer Center

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• 1. Metastatic clear cell renal cell carcinoma, with or without sarcomatoid features, clinically apparent less than 12 months. 2. Male/female participants must be at least 18 years of age on the day of signing informed consent. 3. IMDC risk score of 0 or 1. 4. No prior systemic treatment for ccRCC. Adjuvant immunotherapy or targeted treatments allowed if progressive disease is noted at least 12 months after last dose of immunotherapy. 5. Metastatic disease that is documented by imaging with CT or MRI and measurable by RECIST1.1. 6. Participants must have signed and dated an Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care. 7. Karnofsky performance status ≥ 70% and ECOG PS 0 or 1 8. Suitable for active surveillance in the medical judgment of the treating oncologist. 9. Participants must have adequate organ and marrow function as defined below: i. absolute neutrophil count ≥ 1.5 x 109/L ii. platelets ≥ 100 x 109/L iii. hemoglobin (Hgb) ≥ 9 g/dL iv. total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN) v. AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN vi. serum creatinine ≤ 1.5 × institutional ULN OR 24-hour clearance ≥ 40 mL/min *Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)-AST(SCOT)/ Alanine aminotransferase (serum glutamic-pyruvic transaminase)- ALT(SGPT) 10. A minimum of 28 days from any major surgery prior to registration. 11. Ability to swallow, retain, and absorb oral medication. 12. Baseline oxygen saturation >92% on room air. 13. Female Participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a woman of child-bearing potential (WOCBP) OR
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 30 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 14. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
• Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause as detailed below:
• Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
• Male participants must also agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex.
• Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 15. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Exclusion Criteria:

1. Known or suspected brain metastases or active leptomeningeal disease.
2. Requires any supplemental oxygen (either intermittent or chronic)
3. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with protocol
4. Impairment of gastrointestinal function or disease that may significantly alter the absorption of belzutifan (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease)
5. Prior cardiovascular event including myocardial infarction, rest claudication, stroke, unstable angina, central nervous system (CNS) hemorrhage, unstable ventricular arrythmias, or severe congestive heart failure (NYHA Class 3 or higher) within the past 6 months
6. Received colony-stimulating factors (eg, granulocyte colony stimulating factor, granulocytemacrophage colony stimulating factor or recombinant erythropoietin) ≤28 days prior to the first dose of study intervention.
7. Has moderate to severe hepatic impairment (Child-Pugh B or C).
8. Participants who have undergone major surgery ≤ 28 days prior to starting study drug, radiation ≤ 2 weeks prior to starting study drug, or who have not recovered from side effects of such therapy prior to registration.
9. Has received any type of small molecule kinase inhibitor (including investigational agents) ≤2 weeks before randomization; any prior HIF-2a antagonist exposure.
10. Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan) formulations.
11. Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study.
12. Active infection requiring systemic therapy within 14 days prior to treatment assignment.
13. Has active tuberculosis.
14. Active HBV (defined as HBsAg reactive and detectable HBV viral load) or active HCV (defined as HCV RNA [qualitative] is detected) infection.
15. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
16. Has uncontrolled HIV infection (history of HIV with CD4 count >400 and undetectable HIV viral load while on anti-retroviral therapy allowed).
17. Pregnant women are excluded from this study. Women who are breastfeeding should discontinue prior to initiating treatment.

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Condition: Clear Cell Renal Cell Cancer (ccRCC), Urothelial Carcinoma (UC), Colorectal Cancer, Cervical Cancer, Ovarian Cancer, Head and Neck Cancer, Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Breast Cancer, Pancreatic Cancer, Endometrial Cancer, Von Hippel Lindau Disease

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07557225

Sponsor: Peking University First Hospital

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. All participants must meet the following criteria:
2. Written and voluntarily given Informed Consent.
3. Male or female ≥18 years of age at time of consent.
4. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
5. Participants with histologically confirmed or suspected tumors of the following types, but not limited to: Clear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.

Exclusion Criteria:

1. Participants will be excluded from participation in the study if one or more of the following criteria are met:
2. Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.
3. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.
4. Be a female who is pregnant or breastfeeding.

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