Clinical Trial

PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer

Active, Not Recruiting Phase 1
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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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-02-08; most recent amendment 2026-03-13.
Status change: Recruiting → Active, Not Recruiting 2025-12-01
Status change: Not Yet Recruiting → Recruiting 2022-03-29
Trial Details
NCT Number NCT05245006
Lead Sponsor Robert Flavell, MD, PhD
Collaborators: United States Department of Defense, Fortis Therapeutics, Inc.
Conditions Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Enrollment 30 participants
Start Date 2022-03-18
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-17