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 177LUPSMA RADIOLIGAND THERAPY (RLT)
Brief description of study
This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 with a subsequent Phase 3 efficacy evaluation of FPI-2265 vs SOC in extending rPFS, measured by the PCWG3 criteria, in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT). SOC will be determined by the treating physician/Investigator prior to randomization. FDA-approved novel androgen receptor pathway inhibitors for mCRPC (such as abiraterone or enzalutamide) are allowed. Investigational agents, cytotoxic chemotherapy, immunotherapy, other systemic radioisotopes, and hemi-body radiotherapy are excluded. The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265 dose and regimen for the subsequent efficacy evaluation segment (Phase 3). Conclusions from Phase 2 will be based on safety, tolerability, and anti-tumor activity. The primary objective of Phase 3 is to evaluate the anti-tumor activity, measured by rPFS, in participants with progressive PSMA-positive mCRPC who receive FPI-2265 vs participants treated with SOC.
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