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 dosethe amount of medication taken 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 prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
Intervention / Treatment
- Drug: FPI-2265
- Drug: Olaparib
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 Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells ≤1 (except alopeciathe partial or complete absence of hair from areas of the body where it normally grows; baldness).
- Participants must have had prior orchiectomyremoval of one or both testicles, also known as orchidectomy 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 marrowsoft, spongy tissue found in bones that makes blood cells function:
- Hgb >/= 9g/dL
- Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding >/= 100 x 10^9/L
- ANC </= 1.5 x 10^9/L
- CrCL >/= 50 mL/min