A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer (NCT07030907) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
United States30 participantsStarted 2025-06-16
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years of age at the time of signing the informed consent form.
✓. Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
✓. Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
✓. Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.
✓. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
✓. Measurable disease.
✓. Consent to provide archived tumor tissue sample.
✓. ECOG performance status of 0 or 1.
Exclusion criteria
✕. Women of child-bearing potential who are pregnant or breastfeeding.
✕. Uncontrolled bacterial, fungal, or viral infections.
✕. Active infection requiring systemic therapy.
✕. Bleeding or thrombotic disorders or at risk for severe hemorrhage.