A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
Trial Parameters
Brief Summary
The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101. Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.
Eligibility Criteria
Inclusion 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. Ne