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ACTIVE NOT RECRUITING
NCT06909825
PHASE2

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

Sponsor: Fusion Pharmaceuticals Inc.

View on ClinicalTrials.gov

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

DRUG

FPI-2265

PSMA ligand radiolabeled with Ac225

DRUG

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