RECRUITING

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

Conditions

Metastatic Castration-resistant Prostate Cancer mCRPC 225Ac-PSMA-I&T Radioligand therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2/3, 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), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

Quick Facts

Study Start:2024-03-05

Study Completion:2031-01-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06402331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Phase 2: 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.	* Participants who received more than two prior lines of cytotoxic chemotherapy for CRPC. * Phase 2: 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 from the Phase 2 segment of the study. * 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.

Inclusion Criteria

Exclusion Criteria

* Phase 2: 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.

* Participants who received more than two prior lines of cytotoxic chemotherapy for CRPC.
* Phase 2: 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 from the Phase 2 segment of the study.
* 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.

Contacts and Locations

Study Contact

Clinical Trials Fusion Pharmaceuticals Inc.

CONTACT

1 (888) 506-4215

clinicaltrials@fusionpharma.com

Principal Investigator

Keith Barnett

STUDY_DIRECTOR

Fusion Pharmaceuticals Inc.

Study Locations (Sites)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Hoag Health Center Irvine

Irvine, California, 92618

United States

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073

United States

University of California Los Angeles

Los Angeles, California, 90095

United States

UCSF School of Medicine

San Francisco, California, 94143

United States

Biogenix Molecular, LLC

Miami, Florida, 33165

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

United States

United Theranostics

Glen Burnie, Maryland, 21061

United States

BAMF Health

Grand Rapids, Michigan, 49503

United States

SSM Health Saint Louis University Hospital

Saint Louis, Missouri, 63104

United States

XCancer

Omaha, Nebraska, 68130

United States

New Mexico Oncology Hematology Consultants Ltd.

Albuquerque, New Mexico, 87109

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Memorial Sloan Kettering Cancer Center - NYC

New York, New York, 10065

United States

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

Portland, Oregon, 97239-3098

United States

VA North Texas Health Care System, Nuclear Medicine Service

Dallas, Texas, 75216

United States

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

U.T. MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Fusion Pharmaceuticals Inc.

Keith Barnett, STUDY_DIRECTOR, Fusion Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-05

Study Completion Date2031-01-23

Study Record Updates

Study Start Date2024-03-05

Study Completion Date2031-01-23

Terms related to this study

Keywords Provided by Researchers

mCRPC
225Ac-PSMA-I&T
Radioligand therapy

Additional Relevant MeSH Terms

Metastatic Castration-resistant Prostate Cancer