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