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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)

Trial Profile

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: 30 Apr 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

  • 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).
  • 09 May 2024 Status changed from planning to recruiting, according to Fusion Pharmaceuticals media release.

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