Combination of FPI-2265 and Olaparib for Advanced Prostate Cancer
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)
This study is testing a new combination of two treatments, FPI-2265 and Olaparib, to see if they can help people with advanced prostate cancer feel better and manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Fusion Pharmaceuticals Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Darlinghurst, New South Wales and 7 other locations) |
| Trial ID | NCT06909825 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter study aims to evaluate the efficacy, safety, and tolerability of FPI-2265 (225Ac-PSMA-I&T) in combination with Olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC). The study consists of two parts: one for patients previously treated with certain radioligand therapies and another for those who have not. Participants will receive either of two dosing regimens of FPI-2265 alongside Olaparib, with monitoring for efficacy response, disease progression, and adverse events. The goal is to determine the optimal dosing regimen for this combination therapy.
Who should consider this trial
Good fit: Ideal candidates are adult males with progressing mCRPC who have undergone prior anti-androgen therapy and have positive PSMA PET/CT scans.
Not a fit: Patients who have received certain radioligand therapies within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced prostate cancer that is resistant to standard therapies.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in targeting mCRPC with radioligand therapies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult male participants with mCRPC that is progressing at the time of study entry 2. ECOG performance status 0-1 and life expectancy of at least three months 3. Must have received at least one novel anti-androgen deprivation therapy 4. Participants with known BRCA mutations should have received approved therapies such as PARP inhibitors, per Investigator discretion. 5. All prior treatment-related AEs must have resolved to CTCAE Grade ≤1 (except alopecia). 6. 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) 7. Positive PSMA PET/CT scans . 8. 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 Criteria: 1. Previous treatment with any of the following within 6 months of first dose: Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. 2. Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC. 3. Participants with known unresolved urinary tract obstruction. 4. Transfusion- or growth factor-dependent participants. 5. 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. 6. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 7. Participants with any liver metastases. 8. Participants with skeletal metastases presenting as a superscan . 9. Previous history of interstitial lung disease or non-infectious pneumonitis. 10. Participants with a history or clinical and/or laboratory features suggestive of MDS/AML. 11. Major surgery ≤28 days prior to the first dose of study treatment. 12. Planning to conceive a pregnancy during the treatment and up to six months after the last treatment. 13. Participants unable to swallow orally administered medications or with malabsorptive gastrointestinal disorders. 14. Concomitant use of known strong or moderate CYP3A inhibitors or inducers
Where this trial is running
Darlinghurst, New South Wales and 7 other locations
- St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (Not_yet_recruiting)
- Macquarie University Hospital — Macquarie Park, New South Wales, Australia (Recruiting)
- Icon Cancer Centre North Lakes — North Lakes, Queensland, Australia (Recruiting)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Not_yet_recruiting)
- Icon Cancer Centre Kurralta Park — Kurralta Park, South Australia, Australia (Recruiting)
- Austin Hospital — Heidelberg, Victoria, Australia (Not_yet_recruiting)
- Peter MacCallum Cancer Center — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Fusion Pharmaceuticals, Inc. Sponsor
- Email: clinicaltrials@fusionpharma.com
- Phone: 1(888) 506-4215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.