NCT06909825Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 2, Open-label, Multi-centre Study of FPI-2265 (225Ac-PSMA-I&T) and Olaparib in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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 dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 and Olaparib in participants with metastatic castration-resistant prostate cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- 26 Feb 2025
- Primary completion date
- May 2027
- Lead sponsor
- Fusion Pharmaceuticals Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT06909825
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 85
- From 26 Feb 2025 to the primary completion date, May 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
- Previous history of interstitial lung disease or non-infectious pneumonitis.
- Major surgery ≤28 days prior to the first dose of study treatment.
- Concomitant use of known strong or moderate CYP3A inhibitors or inducers
Other illness
- Participants unable to swallow orally administered medications or with malabsorptive gastrointestinal disorders.
Lab values
- Participants with a history or clinical and/or laboratory features suggestive of MDS/AML.
Other
- Participants with known unresolved urinary tract obstruction.
- Transfusion- or growth factor-dependent participants.
- 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 .
- Planning to conceive a pregnancy during the treatment and up to six months after the last treatment.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icon Cancer Centre Kurralta Park Coordinator of this site? Confirm its status | Kurralta Park | Australia | Unknown status |
| Macquarie University Hospital Coordinator of this site? Confirm its status | Macquarie Park | Australia | Unknown status |
| Peter MacCallum Cancer Center Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.