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Brief Title: FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official Title: 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)
Study ID: NCT06402331
Brief Summary: 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 in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT).
Detailed Description: The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265 dose and regimen. Conclusions from Phase 2 will be based on safety, tolerability, and anti-tumor activity. Participants with PSMA positive scans will be randomized (1:1:1) to one of three different dosing arms: Arm 1: Will consist of nine doses of FPI-2265, administered every four weeks at 50 kBq/kg. Arm 2: Will consist of six doses of FPI-2265, administered every six weeks at 75 kBq/kg. Arm 3: Will consist of four doses of FPI-2265, administered every eight weeks at 100 kBq/kg. Participants will be monitored and assessed for efficacy response, disease progression and adverse events.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
BAMF Health, Grand Rapids, Michigan, United States
XCancer, Omaha, Nebraska, United States
Name: Keith Barnett
Affiliation: Fusion Pharmaceuticals Inc.
Role: STUDY_DIRECTOR