Clinical Trial · NCT06402331

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

Overview

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT). The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265 dose and regimen. Conclusions from Phase 2 will be based on safety, tolerability, and anti-tumor activity. Participants with PSMA positive scans will be randomized (1:1:1) to one of three different dosing arms: Arm 1: Will consist of nine doses of FPI-2265, administered every four weeks at 50 kBq/kg. Arm 2: Will consist of six doses of FPI-2265, administered every six weeks at 75 kBq/kg. Arm 3: Will consist of four doses of FPI-2265, administered every eight weeks at 100 kBq/kg. Participants will be monitored and assessed for efficacy response, disease progression and adverse events.

Sponsor

Fusion Pharmaceuticals, Inc.

Phase

Phase 2

Contacts

Fusion Pharma (N/A)

clinicaltrials@fusionpharma.com

1 (888) 506-4215

ClinicalTrials.gov

NCT06402331

Drug / Compound

Isotope(s):

Target(s):

Eligibility

Inclusion

Positive PSMA PET/CT scan
Progressive mCRPC
Phase 2 ECOG performance status 0 or 1
Must have completed lutetium-PSMA therapy for more than 6 wks before first study drug dose
Participants with known BRCA mutations should have received FDA approved therapies ie PARP inhibitors per PI discretio

Exclusion

Participants with skeletal metastases presented as a superscan on a Tc bone scan
Phase 2:Participants who progress within two cycles of prior treatment of 177Lu-PSMA therapy
Participants with liver metastases will be excluded from Phase 2 of study.
Participants who received more than two prior lines of cytotoxic chemo for CRPC
No system cytotoxic, investigational therapy within 30 days of first dose. No large ext. beam radiotheapy for 4 wks.h

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