PET Imaging Study of 89Zr-DFO-YS5

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Flavell, MD, PhD
• Collaborators: Fortis Therapeutics, Inc.; United States Department of Defense
• Treatments: Antibodies; Immunoglobulins

Criteria

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)(SGOT) <= 3 X institutional upper limit of normal (ULN).

3. Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) <= 3 X institutional ULN.

4. Creatinine clearance >= 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.

7. Currently progressing by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria at the time of study entry.

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.