Actively Recruiting
Phase 2 Study of FG-3246, a CD46-Targeted Antibody-Drug Conjugate, for Treating Metastatic Castration-Resistant Prostate Cancer in Men
Led by Kyntra Bio · Updated on 2026-05-22
75
Participants Needed
20
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating FG-3246, a CD46-targeting antibody-drug conjugate, in men with metastatic castration-resistant prostate cancer mCRPC who have progressed after treatment with one prior second-generation androgen receptor signaling inhibitor but have not received taxane therapy for mCRPC. This Phase 2 study aims to assess the safety, tolerability, pharmacokinetics, and effectiveness of FG-3246 in this patient population. Participants will receive FG-3246 intravenously every 21 days at one of three dose levels 1.8 mgkg, 2.4 mgkg, or 2.7 mgkg. Treatment continues until disease progression, unacceptable side effects, participant or investigator decision to stop, or study closure by the sponsor. The study includes randomized assignment to dosing groups without masking. During the trial, investigators will monitor radiographic progression-free survival, treatment-emergent adverse events, and drug levels in the blood over approximately 25 months. Additional assessments will include response rates, prostate-specific antigen changes, overall survival, and immune response to the drug. Safety and efficacy measures will be collected regularly, with follow-up visits continuing for up to about two years.
CONDITIONS
Brief Title
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Research Team
J
Javier Moreno
M
Mairead Carney
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