Clinical Trial · NCT06909825

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

Overview

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.

Sponsor

Fusion Pharmaceuticals, Inc.

Phase

Phase 2

Contacts

Dipti Shoop (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT06909825

Drug / Compound

PSMA-I&T

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Must have received at least one novel anti-androgen deprivation therapy
Adult male participants with mCRPC that is progressing at the time of study entry
Positive PSMA PET/CT scans .

Exclusion

Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC.
Participants with any liver metastases.
Participants with skeletal metastases presenting as a superscan .
Participants with a history of CNS metastases are excluded, except those who have received therapy (and are neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.

Patient Education

Patient education not yet provided.

Publications

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