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A Phase 2/3, 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), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

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A Phase 2/3, 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), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 25 Feb 2025

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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 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).
    • 09 May 2024 Status changed from planning to recruiting, according to Fusion Pharmaceuticals media release.
    • 07 May 2024 According to Fusion Pharmaceuticals media release,the development plan includes Phase 2 dose optimization lead-in, which aims to evaluate whether there are added safety and/or efficacy benefits of various dosing regimens in comparison to the validated regimen of 100kBq/kg every 8weeks, expected to be initiated in the second quarter of 2024.This Phase 2 portion is expected to complete enrollment of approx 60 patients by the end of 2024,followed by a Phase 3 global registrational trial in 2025.

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