A First-in-Human, Pilot PET Imaging Study of 89Zr-DFO-YS5, an immunoPET Agent for Detecting CD46 Positive Malignancy in Men With Prostate Cancer

209210

CD46 is an exciting new therapeutic target in prostate cancer, with the antibody drug conjugate FOR46 under investigation in phase I clinical trials. The hypothesis of the study is that CD46 expression, measured via our novel imaging biomarker, is a characteristic feature of mCRPC, and particularly common in the most lethal forms of the disease including adenocarcinoma and Small-cell neuroendocrine carcinoma (SCNC). These data will provide crucial information about the feasibility of targeting cluster of differentiation 46 (CD46) in mCRPC, will be used guide the development of novel therapeutic and theranostic agents, to help develop treatments that improve outcomes for men with the most lethal forms of prostate cancer.

2022-03-18

2025-12-31

2025-12-31

Recruiting

Early phase I

24

Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC). 2. Age \>=18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \>60%). 4. Demonstrates adequate organ function as defined below: 1. Total bilirubin \<1.5 X upper limit of normal (ULN). 2. Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \<= 3 X institutional upper limit of normal (ULN). 3. Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \<= 3 X institutional ULN. 4. Serum creatinine \<=1,5 X institutional ULN or calculated creatinine clearance (Glomerular filtration rate (GFR)) \>= 60 mL/min, calculated using the Cockcroft-Gault equation. 5. Ability to understand a written informed consent document, and the willingness to sign it. 6. Individuals 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. Patients who because of age, general medical, or psychiatric condition, or physiologic status cannot give valid informed consent. 2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures. 3. Patients who have received the same antibody (YS5) earlier as part of therapy or detection.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2024-05-31