Trial Title:
FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT ID:
NCT06402331
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
mCRPC
225Ac-PSMA-I&T
Radioligand therapy
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FPI-2265
Description:
PSMA ligand radiolabeled with Ac225
Arm group label:
FPI-2265 100 kBq/kg
Arm group label:
FPI-2265 50 kBq/kg
Arm group label:
FPI-2265 75 kBq/kg
Other name:
Ac225-PSMA I&T
Summary:
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).
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.
Criteria for eligibility:
Criteria:
Key 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.
Key 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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hoag Health Center Irvine
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gary Ulaner, MD
Phone:
949-557-0285
Email:
gary.ulaner@hoag.org
Investigator:
Last name:
Gary Ulaner, MD
Email:
Principal Investigator
Facility:
Name:
VA Greater Los Angeles Healthcare System
Address:
City:
Los Angeles
Zip:
90073
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gholam Berenji, MD
Phone:
310-268-3547
Email:
gholam.berenji@va.gov
Contact backup:
Last name:
Janake Wijesuriya
Phone:
310-977-5209
Email:
janake.wijesuriya@va.gov
Investigator:
Last name:
Gholam Berenji, MD
Email:
Principal Investigator
Facility:
Name:
Biogenix Molecular, LLC
Address:
City:
Miami
Zip:
33165
Country:
United States
Status:
Recruiting
Contact:
Last name:
Milka Vina
Phone:
786-791-1799
Email:
mvina@cira-health.com
Investigator:
Last name:
Frankis Almaguel, MD, PhD
Email:
Principal Investigator
Facility:
Name:
BAMF Health
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brandon Mancini, MD
Phone:
616-330-3343
Email:
brandon.mancini@@bamfhealth.com
Contact backup:
Last name:
Harshad Kulkarni, MD
Email:
harshad.kulkarni@bamfhealth.com
Investigator:
Last name:
Brandon Mancini, MD
Email:
Principal Investigator
Facility:
Name:
SSM Health Saint Louis University Hospital
Address:
City:
Saint Louis
Zip:
63104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chelsea Webb, CNMT
Phone:
314-617-2899
Email:
chelsea.may@health.slu.edu
Investigator:
Last name:
Razi Muzaffar, DO
Email:
Principal Investigator
Facility:
Name:
XCancer
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luke Nordquist, MD
Phone:
402-991-8468
Email:
drluke@xcancer.com
Contact backup:
Last name:
Tony Romero
Phone:
402-697-2229
Email:
tony@xcancer.com
Investigator:
Last name:
Luke Nordquist, MD
Email:
Principal Investigator
Start date:
March 5, 2024
Completion date:
January 23, 2031
Lead sponsor:
Agency:
Fusion Pharmaceuticals Inc.
Agency class:
Industry
Source:
Fusion Pharmaceuticals Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06402331
