Status:
ACTIVE_NOT_RECRUITING
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Lead Sponsor:
Fusion Pharmaceuticals Inc.
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This study is an open-label, multicenter study designed to investigate the efficacy, safety and tolerability of FPI-2265 (225Ac-PSMA-I\&T) in combination with Olaparib in participants with mCRPC. The ...
Detailed Description
This study is an open-label, multicenter study designed to investigate the efficacy, safety and tolerability of FPI-2265 (225Ac-PSMA-I\&T) in combination with Olaparib in participants with mCRPC. The ...
Eligibility Criteria
Inclusion
- Adult male participants with mCRPC that is progressing at the time of study entry
- ECOG performance status 0-1 and life expectancy of at least three months
- Must have received at least one novel anti-androgen deprivation therapy
- Participants with known BRCA mutations should have received approved therapies such as PARP inhibitors, per Investigator discretion.
- All prior treatment-related AEs must have resolved to CTCAE Grade ≤1 (except alopecia).
- Participants must have had prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L)
- Positive PSMA PET/CT scans .
- Participants must have adequate organ and bone marrow function:
- Hgb \>/= 9g/dL
- Platelets \>/= 100 x 10\^9/L
- ANC \</= 1.5 x 10\^9/L
- CrCL \>/= 50 mL/min
Exclusion
- Previous treatment with any of the following within 6 months of first dose: Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.
- Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC.
- Participants with known unresolved urinary tract obstruction.
- Transfusion- or growth factor-dependent participants.
- Participants with a history of CNS metastases are excluded, except those who have received therapy (and are neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.
- Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
- Participants with any liver metastases.
- Participants with skeletal metastases presenting as a superscan .
- Previous history of interstitial lung disease or non-infectious pneumonitis.
- Participants with a history or clinical and/or laboratory features suggestive of MDS/AML.
- Major surgery ≤28 days prior to the first dose of study treatment.
- Planning to conceive a pregnancy during the treatment and up to six months after the last treatment.
- Participants unable to swallow orally administered medications or with malabsorptive gastrointestinal disorders.
- Concomitant use of known strong or moderate CYP3A inhibitors or inducers
Key Trial Info
Start Date :
February 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 12 2030
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06909825
Start Date
February 26 2025
End Date
August 12 2030
Last Update
November 28 2025
Active Locations (4)
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1
Macquarie University Hospital
Macquarie Park, New South Wales, Australia, 2113
2
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
3
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia, 5037
4
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia, 3000