FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate… (NCT06909825) | Clinical Trial Compass
Active — Not RecruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Australia85 participantsStarted 2025-02-26
Plain-language 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 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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.
What they're measuring
1
Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib
Timeframe: From first dose until approximately 12 weeks after the first administered dose of FPI-2265
2
Evaluate the safety and tolerability of FPI-2265 administered in combination with olaparib
Timeframe: From first dose until end of long-term follow-up, 5 years from the last administered dose of FPI-2265
. 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 .