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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Sponsor: Fusion Pharmaceuticals Inc.
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.
Official title: A Phase 2, Open-label, Multi-centre Study of FPI-2265 (225Ac-PSMA-I&T) and Olaparib in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
85
Start Date
2025-02-26
Completion Date
2030-08-12
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
FPI-2265
PSMA ligand radiolabeled with Ac225
Olaparib
Poly (ADP-ribose) polymerase (PARP) inhibitor
Locations (4)
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia