A Phase 2, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 (225Ac-PSMA-I&T) in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Latest Information Update: 15 Oct 2025
At a glance
- Drugs Actinium 225 PSMA imaging and therapy (Primary)
- Indications Adenocarcinoma; Prostate cancer
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms AlphaBreak
- Sponsors Fusion Pharmaceuticals
Most Recent Events
- 09 Oct 2025 The protocol has been amended to change in study phase to phase II/III to phase II.
- 25 Apr 2025 Planned number of patients changed from 60 to 100.
- 09 May 2024 According to Fusion Pharmaceuticals media release, the first patient has been dosed in the Phase 2 portion of the AlphaBreak trial evaluating FPI-2265 (225Ac-PSMA I&T) in patients with metastatic castration-resistant prostate cancer (mCRPC).