Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening) compared to 800 mg daily (split BID 400 mg morning + 400 mg evening) in recurrent, advanced ovarian cancer patients that have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. The optimal dose will be selected based on an integrated analysis of PK/PD, safety, and efficacy data.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent form. 2. Age 18 years or older. 3. Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous/endometrioid histology (independent of BRCA1 and HRD status). 4. Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. 5. Patients have received no more than one line of therapy in the platinum resistant or platinum ineligible setting. Note: Prior ADCs therapy (e.g., Elahere) will not count towards this previous line of therapy. 6. Measurable disease by CT scan or MRI. Note: Baseline tumor assessment will be performed within 4 weeks prior to Day 1 Cycle 1 7. Performance status of ECOG ≤ 1. 8. Patients must have a life expectancy of \>16 weeks. 9. Recovered to Grade 1 or less from prior surgery or acute toxicities of prior rad