A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer

Eligibility Criteria

• 1. Age ≥ 18 years of age at the time of signing the informed consent form.
• 2. Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
• 3. Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
• 4. Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.
• 5. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
• 6. Measurable disease.
• 7. Consent to provide archived tumor tissue sample.
• 8. ECOG performance status of 0 or 1.
• 9. Adequate organ function.
• 10. Alkaline phosphatase ≤ 2.5 x ULN
• 11. ≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) \> 92% on room air.
• 12. LVEF ≥ 50%
• 13. Life expectancy of ≥ 3 months
• 14. Adequate venous access.
• 15. Negative screen for infectious disease markers.
• 16. Negative serum pregnancy test.
• 17. Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.
• 1. Women of child-bearing potential who are pregnant or breastfeeding.
• 2. Uncontrolled bacterial, fungal, or viral infections.
• 3. Active infection requiring systemic therapy.
• 4. Bleeding or thrombotic disorders or at risk for severe hemorrhage.
• 5. Any form of primary immunodeficiency.
• 6. Had an allogenic tissue/solid organ transplant.
• 7. Active autoimmune disease.
• 8. Concurrent treatment with systemic high dose corticosteroids.
• 9. Unresolved acute effects of any prior therapy.
• 10. Active invasive cancer other than the cancer under study.
• 11. Significant lung disease.
• 12. Clinically significant pericardial effusion.
• 13. Prior radiotherapy within 2 weeks of start of study intervention.
• 14. No major surgery within 28 days prior to enrollment.
• 15. Received investigational agents or tumor vaccines.
• 16. Received chemotherapy within the previous 3 weeks.
• 17. History of grade ≥ 3 ascites.
• 18. Active CNS involvement.
• 19. Received a live vaccine within 30 days prior to study treatment.
• 20. Received prior CAR T cell therapy.
• 21. Received prior mesothelin targeted therapy.
• 22. Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria could apply