FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT ID: NCT06402331
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2024-03-05
2031-01-23
Brief Summary
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Detailed Description
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Screening Period: At screening, participants will be assessed for eligibility and undergo a positron emission tomography (PET)/computed tomography (CT) scan to evaluate PSMA positivity. Only participants with PSMA positive cancer and confirmed eligibility criteria will be randomized.
Participants randomized will enter the treatment period and receive investigational doses of FPI2265 according to the dose level and schedule as specified per proposed dose arm.
Part A participants will enroll 1:1:1 at three dose level/schedules, to arms 1, 2 or 3
Part B participants will enroll after completion of part A, in a 1:1 randomization scheme to arms 6 or 7.
Once Part A is fully enrolled and participants have been followed for at least 12 weeks, data from Arm 1 and 2 will be analyzed to assess the feasibility of enrolling participants to arms 4 and 5.
All participants will be monitored and assessed for efficacy response, disease progression and adverse events.
Supportive care will be allowed in all arms at the discretion of the investigator and includes available care for the eligible participant according to best institutional practice for mCRPC treatment, including androgen deprivation therapy (ADT).
Follow-up after end of treatment visit will proceed for 5 years.
5 participants will be enrolled into a dosimetry substudy (open at select sites only). Dosimetry substudy participants will be administered one dose at of FPI2265 and proceed with dosimetric assessments will be taken at a number of timepoints after dose administration.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A Arm 1
FPI-2265
Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.
Other Names:
225Ac-PSMA-I\&T
Part A Arm 2
FPI-2265
Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.
Other Names:
225Ac-PSMA-I\&T
Part A Arm 3
FPI-2265
Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.
Other Names:
225Ac-PSMA-I\&T
Part B Arm 4
to be utilized based on analysis of Part A
FPI-2265
Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.
Other Names:
225Ac-PSMA-I\&T
Part B Arm 5
to be utilized based on analysis of Part A
FPI-2265
Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.
Other Names:
225Ac-PSMA-I\&T
Part B Arm 6
FPI-2265
Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.
Other Names:
225Ac-PSMA-I\&T
Part B Arm 7
FPI-2265
Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.
Other Names:
225Ac-PSMA-I\&T
Interventions
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FPI-2265
Investigational treatment FPI2265 is a PSMA ligand radiolabelled with 225Ac.
Other Names:
225Ac-PSMA-I\&T
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
MALE
No
Sponsors
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Fusion Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Keith Barnett
Role: STUDY_DIRECTOR
Fusion Pharmaceuticals Inc.
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Hoag Health Center Irvine
Irvine, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
UCSF School of Medicine
San Francisco, California, United States
Biogenix Molecular, LLC
Miami, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
United Theranostics
Glen Burnie, Maryland, United States
BAMF Health
Grand Rapids, Michigan, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, United States
XCancer
Omaha, Nebraska, United States
New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center - NYC
New York, New York, United States
Oregon Health and Science University (OHSU, Knight Cancer Center)
Portland, Oregon, United States
VA North Texas Health Care System, Nuclear Medicine Service
Dallas, Texas, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
U.T. MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FPI-2265-202
Identifier Type: -
Identifier Source: org_study_id
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