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Not recruiting

Phase 2

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

Sponsor:

Fusion Pharmaceuticals Inc.

Code:

NCT06402331

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FPI-2265

Study Details

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT06402331

Start date

Mar 5, 2024

Status verified date

Oct, 2025

Completion date

Jan 23, 2031

Anticipated

Primary completion date

Jul 23, 2026

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Key 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.

Key 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A Arm 1

experimental: Part A Arm 2

experimental: Part A Arm 3

experimental: Part B Arm 4

to be utilized based on analysis of Part A

experimental: Part B Arm 5

to be utilized based on analysis of Part A

experimental: Part B Arm 6

experimental: Part B Arm 7

Interventions

FPI-2265

Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.

Other Names:

225Ac-PSMA-I\&T

Primary outcome measure

Frequency, duration, and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: From first dose until end of long-term follow-up, 5 years from end of treatment visit. ]
Frequency and proportion of participants with PSA50 response [ Time Frame: From first dose until 12 weeks after the first administered dose of FPI-2265. ]

Central Contacts and Locations

Central contacts

Clinical Trials Fusion Pharmaceuticals Inc.

1 (888) 506-4215 clinicaltrials@fusionpharma.com

Locations

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Jennifer Simpson

+ (626) 218 5087 jSimpson@coh.org

Jessica Liu

+ (626) 218 0473 jesliu@coh.org

Principal Investigator:

Jeffrey Wong, MD

Hoag Health Center Irvine

Recruiting

Irvine, California, United States, 92618

Contacts

Gary Ulaner, MD

949-557-0285 gary.ulaner@hoag.org

Principal Investigator:

Gary Ulaner, MD

VA Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 90073

Contacts

Gholam Berenji, MD

310-268-3547 gholam.berenji@va.gov

Janake Wijesuriya

310-977-5209 janake.wijesuriya@va.gov

Principal Investigator:

Gholam Berenji, MD

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Deepu Varughese

+1 (310) 206 7372 DVarughese@mednet.ucla.edu

Stephanie Lira

+310 (206) 7372 StephanieLira@mednet.ucla.edu

Principal Investigator:

Jeremie Calais, MD

UCSF School of Medicine

Recruiting

San Francisco, California, United States, 94143

Contacts

Maya Aslam

+1 (415) 514 8987 maya.aslam@ucsf.edu

Lisa Kody

+ (310) 983 1444 Lisa.kody@ucsf.edu

Principal Investigator:

Ivan De Kouchkovsky, MD

Biogenix Molecular, LLC

Recruiting

Miami, Florida, United States, 33165

Contacts

Jerry Joseph, Site Administrator

786-791-1799 jjoseph@cira-health.com

Principal Investigator:

Frankis Almaguel, MD, PhD

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Debra OConnell-Moore

319-356-1693 debra-oconnell-moore@uiowa.edu

Principal Investigator:

Yusuf Menda, MD

BAMF Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Brandon Mancini, MD

(616) 330-3343 brandon.mancini@@bamfhealth.com

Harshad Kulkarni, MD

harshad.kulkarni@bamfhealth.com

Principal Investigator:

Brandon Mancini, MD

SSM Health Saint Louis University Hospital

Recruiting

St Louis, Missouri, United States, 63104

Contacts

Chelsea Webb, CNMT

(314) 617-2899 chelsea.may@health.slu.edu

Principal Investigator:

Razi Muzaffar, DO

XCancer

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Luke Nordquist, MD

402-991-8468 drluke@xcancer.com

Tony Romero

402-697-2229 tony@xcancer.com

Principal Investigator:

Luke Nordquist, MD

New Mexico Oncology Hematology Consultants Ltd.

Recruiting

Albuquerque, New Mexico, United States, 87109

Contacts

Kimberly Demos

505 -317-2605 KimberlyD@nmohc.com

Principal Investigator:

Gregg Franklin, MD

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Scarlett Rodriguez

929-334-6980 Scarlett.Rodriguez@nyulangone.org

Carol Fernandez Guerra

917-696-0226 Carol.FernandezGuerra@nyulangone.org

Principal Investigator:

David Wise, MD

Memorial Sloan Kettering Cancer Center - NYC

Recruiting

New York, New York, United States, 10065

Contacts

MSKCC Clinical Trials Contact

888-906-0432 neemuci@mskcc.org

Principal Investigator:

Michael Morris, MD

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

Recruiting

Portland, Oregon, United States, 97239-3098

Contacts

Justina Lynch

+ (503) 418 9737 lynchjus@ohsu.edu

Principal Investigator:

Alexandra Sokolova, MD

VA North Texas Health Care System, Nuclear Medicine Service

Recruiting

Dallas, Texas, United States, 75216

Contacts

Jessica Bhatti

+ (512) 341 8724 jessica.bhatti@va.gov

Maximillian Masuda

+ (214) 742 8387 maximillian.masuda@va.gov

Principal Investigator:

Irfan Farukhi

The University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Michael Fulkerson

214-648-5984 Michael.Fulkerson@UTSouthwestern.edu

Principal Investigator:

Orhan OZ, Prof

U.T. MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Virginia Bayer

+ (713) 517 0790 VRBayer@mdanderson.org

Emily Batton

+ (713) 563 2634 edjones2@mdanderson.org

Principal Investigator:

Amado Zurita-Saavedra, MD

More Information

Sponsor

Fusion Pharmaceuticals Inc.

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

mCRPC
225Ac-PSMA-I&T
Radioligand therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Fusion Pharmaceuticals Inc. on 2025-10-09.