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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib — From first dose until approximately 12 weeks after the first administered dose of FPI-2265 The frequency and proportion of participants with PSA50 response will be summarized, where PSA50 is defined as ≥50% decline in PSA level from pre-treatment.
Evaluate the safety and tolerability of FPI-2265 administered in combination with olaparib — From first dose until end of long-term follow-up, 5 years from the last administered dose of FPI-2265 Safety will be assessed by percentage of patient with treatment emergent adverse events and serious adverse events; percentage of patients with SAEs during the first year of the long term follow up and the number of AESIs during the 5 year follow up period. Percentage of patients with interruption of FPI-2265; percentage of patients who discontinue treatment; number and grade for AEs related to study treatment.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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