A First-in-Human, Phase I PET Imaging Study of 11C-YJH08, a Selective Glucocorticoid Receptor-Targeting Agent, in Patients With Advanced Solid Tumor Malignancies
Condition: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Solid Tumor, Adult, Solid Tumor, Metastatic Castration-resistant Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04927663
Sponsor: Rahul Aggarwal
Phase: Phase 1
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
Inclusion Criteria:
- 1.
Disease Characteristics:
- by cohort, as defined by:
- COHORT A: Histologically confirmed metastatic solid tumor malignancy.
- COHORT B: Metastatic castration-resistant prostate cancer with progression on systemic therapies by PCWG3.
- COHORT C: Metastatic advanced solid tumor malignancy other than prostate adenocarcinoma with at least one metastasis on conventional imaging. 2. The subject is able and willing to comply with study procedures and provide signed and dated informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Age 18 years or older at the time of study entry. 5. Adequate organ function, as defined by: 1. Serum creatinine =< 1.5 x upper limit of normal (ULN) OR estimated creatinine clearance > 50 ml/min 2. Total bilirubin =< 1.5 x ULN 3. Hemoglobin >= 8.0 g/dL 4. Platelet count >= 50,000/microliter 5. Absolute neutrophil count >= 1000/microliter
Exclusion Criteria:
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Concurrent treatment with any dose of systemic glucocorticoids within 7 days prior to cycle 1 day 1 (C1D1).
- History of adrenal insufficiency requiring use of systemic glucocorticoid replacement.
- History of Cushing's disease or Cushing's syndrome.
- Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures.
- Contra-indication to MRI (e.g. pacemaker placement, severe claustrophobia) (applicable only for patients scheduled for PET/MRI).
View trial on ClinicalTrials.gov