FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Korábbi kezelés

• 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

Más betegség

• Participants unable to swallow orally administered medications or with malabsorptive gastrointestinal disorders.

Laborértékek

• Participants with a history or clinical and/or laboratory features suggestive of MDS/AML.

Egyéb

• 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.

• 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