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Not Yet Recruiting NCT07926048

A Study of QLS5132 in Platinum-Resistant Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Conditions: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 420
Sponsor: Qilu Pharmaceutical Co., Ltd.

Summary

The goal of this interventional study is to compare the effectiveness and safety of QLS5132 monotherapy with investigator's choice of chemotherapy in participants with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Eligibility Criteria

Inclusion Criteria: * Female participants aged ≥ 18 years. * Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. * Platinum-resistant recurrent disease, defined as disease progression within 6 months (≤183 days) after the last platinum-based chemotherapy. * At least one measurable lesion per RECIST v1.1. * ECOG performance status of 0 or 1. * Expected survival ≥ 12 weeks. * Adequate organ and bone marrow function. * Negative pregnancy test for women of childbearing potential, and agreement to use effective contraception. Exclusion Criteria: * Prior treatment with CLDN6-targeting therapy or topoisomerase I inhibitors (e.g., topotecan, trastuzumab deruxtecan). * Active or untreated central nervous system (CNS) metastases or carcinomatous meningitis. (Patients with stable, treated CNS metastases may be eligible). * Clinically significant cardiovascular disease, including QTc ≥ 470 ms, LVEF \< 50%, or uncontrolled hypertension. * Active infections (e.g., HBV, HCV, HIV, tuberculosis, syphilis). * Active or history of autoimmune diseases requiring systemic treatment. * Severe liver disease (Child-Pugh B or C), uncontrolled diabetes, or other severe medical conditions that may interfere with the study.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07926048). StuddyBuddy aggregates publicly available trial information.