Condition: Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma, RCC, Clear Cell Renal Cell Carcinoma Metastatic, ccRCC, VHL-Associated Clear Cell Renal Cell Carcinoma, VHL-Associated Renal Cell Carcinoma, Kidney Cancer Metastatic, Kidney Cancers

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07300241

Sponsor: Neomorph, Inc

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

• Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).
• Subjects must have progressed on or refused standard therapies.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
• Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.
• Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study.
• Measurable disease as defined by RECIST v1.1.
• Adequate hematologic, hepatic, and renal function defined as:
• Hemoglobin ≥10 g/dL,
• Absolute neutrophil count ≥1000 cells/µL,
• Platelet count ≥100,000/µL,
• AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases,
• Total bilirubin ≤1.5 × ULN,
• Estimated glomerular filtration rate (eGFR) ≥60 mL/min.
• Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug.
• Other inclusion criteria per protocol. Exclusion Criteria:
• Non-clear cell predominant RCC histologic subtypes.
• Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.
• Prior or concurrent malignancies with exceptions per protocol.
• History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.
• Other

Exclusion Criteria:

• Non-clear cell predominant RCC histologic subtypes.
• Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.
• Prior or concurrent malignancies with exceptions per protocol.
• History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.
• Other exclusion criteria per protocol.

View trial on ClinicalTrials.gov