Status:
ACTIVE_NOT_RECRUITING
PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer
Lead Sponsor:
Robert Flavell, MD, PhD
Collaborating Sponsors:
United States Department of Defense
Fortis Therapeutics, Inc.
Conditions:
Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 expressio...
Detailed Description
This single center imaging study involves one microdose of the imaging agent, followed by whole body PET imaging. Imaging data will be acquired in up to four PET studies to determine tumor and normal ...
Eligibility Criteria
Inclusion
- Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC).
- Age \>=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \>60%).
- Demonstrates adequate organ function as defined below:
- Total bilirubin \<1.5 X upper limit of normal (ULN).
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \<= 3 X institutional upper limit of normal (ULN).
- Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \<= 3 X institutional ULN.
- Serum creatinine \<=1,5 X institutional ULN or calculated creatinine clearance (Glomerular filtration rate (GFR)) \>= 60 mL/min, calculated using the Cockcroft-Gault equation.
- Ability to understand a written informed consent document, and the willingness to sign it.
- 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
- Patients who because of age, general medical, or psychiatric condition, or physiologic status cannot give valid informed consent.
- Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05245006
Start Date
March 18 2022
End Date
December 31 2025
Last Update
December 5 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143