Clinical Trial

FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer

Active, Not Recruiting Phase 1/2
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Summary
This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high levels in numerous cancer types. The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-08-11; most recent amendment 2025-08-25.
Status change: Recruiting → Active, Not Recruiting 2025-08-25
Status change: Not Yet Recruiting → Recruiting 2022-01-31
Trial Details
NCT Number NCT05011188
Lead Sponsor Rahul Aggarwal
Collaborators: Fortis Therapeutics, Inc., Kyntra Bio
Conditions Metastatic Castration-resistant Prostate Cancer, Prostate Cancer
Enrollment 44 participants
Start Date 2022-01-19
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-27