Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

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Source: NCT06402331

Active, not recruiting

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

Prostate Cancer

Phase 2

Multi-Site Study

United States of America

Sponsor: Fusion Pharmaceuticals

Last Updated: October 9, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Show Detailed Description

Study Type

Therapeutic

Radiation

Alpha

Radiopharmaceutical

Ac-225 PSMA I&T

Target

PSMA

Trial Started

March 5, 2024

Last Updated by Sponsor

October 9, 2025

Estimated Completion

July 23, 2026

Eligibility

Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

* Diagnosis of adenocarcinoma of prostate proven by histopathology.

* Must have had prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone

* Progressive mCRPC at time of study entry.

* Must have been previously treated with lutetium-PSMA therapy (lutetium-177 vipivotide tetraxetan or other lutetium-177-PSMA RLT). Treatment must have been completed >6 weeks prior to the first dose of study drug.

* Participants with known BRCA mutations should have received FDA-approved therapies such as PARP inhibitors, per Investigator discretion.

* Positive PSMA PET/CT scan

* Adequate organ function

* For participants who have partners of childbearing potential: Partner and/or participant must not be planning to conceive and must use a method of birth control with adequate barrier protection deemed acceptable by the Principal Investigator during the study treatment and for six months after last study drug administration.

Exclusion Criteria

* Participants who received more than two prior lines of cytotoxic chemotherapy for CRPC.

* Participants who progress prior to administration of the 3rd cycle of prior treatment with 177Lu-PSMA therapy

* All prior treatment-related adverse events must have resolved to Grade ≤1 (CTCAE v5.0). Alopecia and stable persistent Grade 2 peripheral neuropathy may be allowed at the discretion of the Investigator.

* Participants with known, unresolved, urinary tract obstruction are excluded.

* Administration of any systemic cytotoxic or investigational therapy ≤30 days of the first dose of study treatment or five half-lives, whichever is shorter. Completion of large-field external beam radiotherapy ≤four weeks of the first dose of study treatment.

* Participants with a history of central nervous system (CNS) metastases are excluded except those who have received therapy

* Participants with any liver metastases will be excluded

* Participants with skeletal metastases presented as a superscan on a ⁹⁹ᵐTc bone scan.

* Previous or concurrent cancer that is distinct from the cancer under investigation in primary site or histology, except treated cutaneous basal cell carcinoma or squamous cell carcinoma and superficial bladder tumors. Any cancer curatively treated >two years prior to the first dose of treatment is permitted.

* Concurrent serious (as determined by the investigator) medical conditions

* Major surgery ≤30 days prior to the first dose of study treatment.

Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll100

Arms & Interventions

Arms

Interventions

Type: Experimental

Description:

Interventions:

FPI-2265

Outcome Measures

Primary Outcome Measures

Frequency, duration, and severity of treatment-emergent adverse events (TEAEs)From first dose until end of long-term follow-up, 5 years from end of treatment visit.

Frequencies and percentages of participants with TEAEs will be summarized. Analysis will also be completed regarding duration of TEAEs and their severity.

Frequency and proportion of participants with PSA50 responseFrom first dose until 12 weeks after the first administered dose of FPI-2265.

PSA50 response is defined as a decline in PSA levels by at least 50% and is used to evaluate anti-tumor activity.

Secondary Outcome Measures

None

Trial Sites

This study has 18 trial sites

University of Iowa Hospitals and Clinics
Iowa City, Iowa, US

Recruiting

Iowa City, Iowa, 52242 US

University of Iowa Hospitals and Clinics

Recruiting

Duarte, California, 91010 US

City of Hope Comprehensive Cancer Center

Recruiting

New York, New York, 10016 US

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Recruiting

Dallas, Texas, 75390 US

The University of Texas Southwestern Medical Center

Recruiting

Los Angeles, California, 90095 US

University of California Los Angeles

Recruiting

Los Angeles, California, 90073 US

VA Greater Los Angeles Healthcare System

Recruiting

San Francisco, California, 94143 US

UCSF School of Medicine

Recruiting

Houston, Texas, 77030 US

U.T. MD Anderson Cancer Center

Recruiting

Grand Rapids, Michigan, 49503 US

BAMF Health

Recruiting

Omaha, Nebraska, 68130 US

XCancer

Recruiting

Miami, Florida, 33165 US

Biogenix Molecular, LLC

Recruiting

Albuquerque, New Mexico, 87109 US

New Mexico Oncology Hematology Consultants Ltd.

Recruiting

Irvine, California, 92618 US

Hoag Health Center Irvine

Active, not recruiting

Glen Burnie, Maryland, 21061 US

United Theranostics

Recruiting

New York, New York, 10065 US

Memorial Sloan Kettering Cancer Center - NYC

Recruiting

Portland, Oregon, 97239-3098 US

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

Recruiting

Dallas, Texas, 75216 US

VA North Texas Health Care System, Nuclear Medicine Service

Recruiting

St Louis, Missouri, 63104 US

SSM Health Saint Louis University Hospital

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