drugset / Trial / NCT06402331

FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06402331

Phase 2 Active not recruiting 110 enrolled Fusion Pharmaceuticals Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-03-05
Primary completion
2026-12-23
Completion
2031-01-23

Drugs

EvaluationDrugModalityDoseRoute
Subject FPI-2265 Small molecule