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

Launched by OUTPACE BIO, INC. · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called OPB-101 for women with ovarian cancer that has come back and does not respond to platinum-based chemotherapy, a common cancer treatment. The main goal is to find out if OPB-101 is safe to use and to determine the best dose for patients. OPB-101 is made by taking a patient’s own immune cells, called T cells, and changing them in a lab before giving them back to the patient in a single treatment. After receiving OPB-101 in the hospital, participants will have regular check-ups for the first few months to monitor their health.

Women who may be eligible for this trial are adults diagnosed with a specific type of ovarian cancer that has returned within six months after platinum chemotherapy and have already tried at least two different chemotherapy treatments. Participants need to be in good enough health to take part, including having certain organ functions within a safe range and not having serious infections or other health problems that could increase risks. It’s important to know that this trial is not yet recruiting participants, and women who are pregnant, breastfeeding, or have certain medical conditions won’t be able to join. This study offers a chance for women with limited treatment options to try a new, personalized therapy that aims to help their immune system fight the cancer.

Gender

FEMALE

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. Negative serum pregnancy test.
• • 17. Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.
• • Note: Other protocol defined inclusion criteria could apply
• Exclusion Criteria:
• • 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