🏛️ Verified NIH Record • Updated 2026-04-02
FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) (NCT06402331)
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Fusion Pharmaceuticals Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope Comprehensive Cancer Center — Duarte, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- City of Hope Comprehensive Cancer Center — Duarte, California
- Hoag Health Center Irvine — Irvine, California
- VA Greater Los Angeles Healthcare System — Los Angeles, California
- University of California Los Angeles — Los Angeles, California
- UCSF School of Medicine — San Francisco, California
- Biogenix Molecular, LLC — Miami, Florida
- University of Iowa Hospitals and Clinics — Iowa City, Iowa
- United Theranostics — Glen Burnie, Maryland
- BAMF Health — Grand Rapids, Michigan
- SSM Health Saint Louis University Hospital — St Louis, Missouri
- XCancer — Omaha, Nebraska
- New Mexico Oncology Hematology Consultants Ltd. — Albuquerque, New Mexico
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York
- Memorial Sloan Kettering Cancer Center - NYC — New York, New York
- Oregon Health and Science University (OHSU, Knight Cancer Center) — Portland, Oregon
- VA North Texas Health Care System, Nuclear Medicine Service — Dallas, Texas
- The University of Texas Southwestern Medical Center — Dallas, Texas
- U.T. MD Anderson Cancer Center — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.