FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Purpose
This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT).
Condition
- Metastatic Castration-resistant Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements. - 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. - 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. - Phase 2: participants who progress within two cycles 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.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental FPI-2265 50 kBq/kg |
Arm 1: FPI-2265 administered by IV injection every four weeks; up to 9 doses. |
|
|
Experimental FPI-2265 75 kBq/kg |
Arm 2: FPI-2265 administered by IV injection every six weeks; up to 6 doses. |
|
|
Experimental FPI-2265 100 kBq/kg |
Arm 3: FPI-2265 administered by IV injection every eight weeks; up to 4 doses. |
|
Recruiting Locations
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
Hoag Health Center Irvine
Irvine, California 92618
Irvine, California 92618
VA Greater Los Angeles Healthcare System
Los Angeles, California 90073
Los Angeles, California 90073
University of California Los Angeles
Los Angeles, California 90095
Los Angeles, California 90095
UCSF School of Medicine
San Francisco, California 94143
San Francisco, California 94143
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
United Theranostics
Glen Burnie, Maryland 21061
Glen Burnie, Maryland 21061
BAMF Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
SSM Health Saint Louis University Hospital
Saint Louis, Missouri 63104
Saint Louis, Missouri 63104
New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
New York, New York 10016
Memorial Sloan Kettering Cancer Center - NYC
New York, New York 10065
New York, New York 10065
Oregon Health and Science University (OHSU, Knight Cancer Center)
Portland, Oregon 97239-3098
Portland, Oregon 97239-3098
VA North Texas Health Care System, Nuclear Medicine Service
Dallas, Texas 75216
Dallas, Texas 75216
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
U.T. MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
More Details
- NCT ID
- NCT06402331
- Status
- Recruiting
- Sponsor
- Fusion Pharmaceuticals Inc.
Study Contact
Clinical Trials Fusion Pharmaceuticals Inc.1 (888) 506-4215
clinicaltrials@fusionpharma.com
Detailed Description
The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265 dose and regimen. Conclusions from Phase 2 will be based on safety, tolerability, and anti-tumor activity. Participants with PSMA positive scans will be randomized (1:1:1) to one of three different dosing arms: Arm 1: Will consist of nine doses of FPI-2265, administered every four weeks at 50 kBq/kg. Arm 2: Will consist of six doses of FPI-2265, administered every six weeks at 75 kBq/kg. Arm 3: Will consist of four doses of FPI-2265, administered every eight weeks at 100 kBq/kg. Participants will be monitored and assessed for efficacy response, disease progression and adverse events.