FPI-2265 for Metastatic Prostate Cancer
(AlphaBreak Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had any systemic cytotoxic or investigational therapy within 30 days before the first dose of the study treatment.
What data supports the effectiveness of the drug FPI-2265 for metastatic prostate cancer?
What safety data exists for FPI-2265 (225Ac-PSMA-I&T) in humans?
In a study with 14 patients using 225Ac-PSMA-I&T for advanced prostate cancer, no acute toxicity was observed during treatment. Some patients experienced side effects like anemia (low red blood cell count) and leukopenia (low white blood cell count), but these were generally manageable. Additionally, mild to moderate dry mouth was noted in some patients.56789
What makes the drug FPI-2265 unique for treating metastatic prostate cancer?
FPI-2265 (225Ac-PSMA-I&T) is unique because it uses targeted alpha therapy (TAT) to deliver alpha-particle radiation directly to prostate cancer cells that express PSMA (prostate-specific membrane antigen), which can be effective even when other treatments have failed. This approach is promising for patients with advanced metastatic castration-resistant prostate cancer, especially those who have not responded to or have developed resistance to other therapies like 177Lu-PSMA.2361011
Research Team
Keith Barnett
Principal Investigator
Fusion Pharmaceuticals Inc.
Eligibility Criteria
This trial is for individuals with metastatic castration-resistant prostate cancer (mCRPC) that shows PSMA positivity. Participants must have previously undergone treatment with a specific type of radioligand therapy using 177Lu-PSMA.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FPI-2265 in one of three dosing regimens: Arm 1 (9 doses every 4 weeks), Arm 2 (6 doses every 6 weeks), or Arm 3 (4 doses every 8 weeks)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of PSA50 response and adverse events
Long-term follow-up
Participants are monitored for long-term safety and efficacy, including treatment-emergent adverse events
Treatment Details
Interventions
- FPI-2265 (225Ac-PSMA-I&T)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fusion Pharmaceuticals Inc.
Lead Sponsor