drugset / Trial / NCT06909825

FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06909825

Phase 2 Active not recruiting 85 enrolled Fusion Pharmaceuticals Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is an open-label, multicenter study designed to investigate the efficacy, safety and tolerability of FPI-2265 (225Ac-PSMA-I\&T) in combination with Olaparib in participants with mCRPC. The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 and Olaparib in participants with metastatic castration-resistant prostate cancer.

Timeline

Start
2025-02-26
Primary completion
2027-05
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject FPI-2265 Small molecule Intravenous
Subject Olaparib Small molecule