Clinical Trial

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

Study acronym: AlphaBreak
Active, Not Recruiting Phase 2
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Summary
This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I\&T). Patient population is adult participants with PSMA positive mCRPC who have had previous treatment with with 177Lu-PSMA-617 or another 177Lu-PSMA radioconjugate (RC). The purpose of the study is to determine the safety and tolerability, and recommended dose and regiment of FPI-2265.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2024-05-02; most recent amendment 2026-04-02.
Status change: Recruiting → Active, Not Recruiting 2026-04-02
Trial Details
NCT Number NCT06402331
Lead Sponsor Fusion Pharmaceuticals Inc.
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 110 participants
Start Date 2024-03-05
Primary Completion 2026-12-23 (estimated)
Study Completion 2031-01-23 (estimated)
Updated on ClinicalTrials.gov 2026-04-08