RecruitingPhase 2NCT06402331

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

A Phase 2, 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)

Sponsor

Fusion Pharmaceuticals Inc.

Enrollment

100 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing FPI-2265, a new targeted radioactive treatment (using a radioactive form of actinium-225 attached to a PSMA-targeting molecule) for men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has already been treated with a similar lutetium-based radioactive therapy. **You may be eligible if...** - You have confirmed prostate adenocarcinoma that has spread and is no longer responding to hormone therapy - You have had prior treatment with lutetium-PSMA therapy (completed at least 6 weeks before starting this study) - You have PSMA-positive cancer confirmed by PET scan - Your overall health is good (ECOG score 0 or 1) and organ function is adequate **You may NOT be eligible if...** - You have had more than two prior courses of chemotherapy for castration-resistant disease - You have liver metastases - Your bone metastases are so widespread they appear as a "superscan" - You have unresolved urinary tract obstruction - You have had major surgery or recent radiation within 4 weeks of starting - You have active CNS (brain or spinal) metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFPI-2265

Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac. Other Names: 225Ac-PSMA-I\&T

Locations(18)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Hoag Health Center Irvine

Irvine, California, United States

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

UCSF School of Medicine

San Francisco, California, United States

Biogenix Molecular, LLC

Miami, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

United Theranostics

Glen Burnie, Maryland, United States

BAMF Health

Grand Rapids, Michigan, United States

SSM Health Saint Louis University Hospital

St Louis, Missouri, United States

XCancer

Omaha, Nebraska, United States

New Mexico Oncology Hematology Consultants Ltd.

Albuquerque, New Mexico, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center - NYC

New York, New York, United States

Oregon Health and Science University (OHSU, Knight Cancer Center)

Portland, Oregon, United States

VA North Texas Health Care System, Nuclear Medicine Service

Dallas, Texas, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

U.T. MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06402331

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