XCancer
Fusion Pharmaceuticals, Inc.

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

Description:

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)

Government Study Link:

NCT06909825 - Click here to see study on

ClinicalTrials.gov

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
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.

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