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

NCT06402331 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FPI-2265-202
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 18

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

Keywords

mCRPC; 225Ac-PSMA-I&T; Radioligand therapy

Outcome Measures

Primary Outcomes (2)

• Frequency, duration, and severity of treatment-emergent adverse events (TEAEs)

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

  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

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

  From first dose until 12 weeks after the first administered dose of FPI-2265.

Study Arms (7)

Part A Arm 1

EXPERIMENTAL

Drug: FPI-2265

Part A Arm 2

EXPERIMENTAL

Drug: FPI-2265

Part A Arm 3

EXPERIMENTAL

Drug: FPI-2265

Part B Arm 4

EXPERIMENTAL

to be utilized based on analysis of Part A

Drug: FPI-2265

Part B Arm 5

EXPERIMENTAL

to be utilized based on analysis of Part A

Drug: FPI-2265

Part B Arm 6

EXPERIMENTAL

Drug: FPI-2265

Part B Arm 7

EXPERIMENTAL

Drug: FPI-2265

Interventions

FPI-2265 DRUG

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

Part A Arm 1; Part A Arm 2; Part A Arm 3; Part B Arm 4; Part B Arm 5; Part B Arm 6; Part B Arm 7

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fusion Pharmaceuticals Inc.: lead

Study Sites (18)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Hoag Health Center Irvine

Irvine, California, 92618, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

UCSF School of Medicine

San Francisco, California, 94143, United States

Location

Biogenix Molecular, LLC

Miami, Florida, 33165, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

United Theranostics

Glen Burnie, Maryland, 21061, United States

Location

BAMF Health

Grand Rapids, Michigan, 49503, United States

Location

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63104, United States

Location

XCancer

Omaha, Nebraska, 68130, United States

Location

New Mexico Oncology Hematology Consultants Ltd.

Albuquerque, New Mexico, 87109, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center - NYC

New York, New York, 10065, United States

Location

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

Portland, Oregon, 97239-3098, United States

Location

VA North Texas Health Care System, Nuclear Medicine Service

Dallas, Texas, 75216, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

U.T. MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Study Officials

• Charlotte Hawkins, MPH, CCRP, PMP

  Fusion Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 7, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): January 23, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (18)