Testing QLS5132 Against Chemotherapy in Ovarian, Fallopian Tube, or Peritoneal Cancer
Compares QLS5132 with standard chemotherapy in adults with returning platinum-resistant ovarian cancer.
Plain-language title generated from the registry record
Registry title: A Study of QLS5132 in Platinum-Resistant Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Key facts
- Phase
- Phase 3
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Pharmaceutical Co., Ltd.
- Trial code
- NCT07926048
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of QLS5132 Versus Investigator's Choice of Chemotherapy in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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.
Inclusion: 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: Prior treatment with CLDN6-targeting therapy or topoisomerase I inhibitors (e.g., topotecan, trastuzumab deruxtecan); 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; Clinically significant cardiovascular disease, including QTc ≥ 470 ms, LVEF < 50%, or uncontrolled hypertension; Active or untreated central nervous system (CNS) metastases or carcinomatous meningitis. (Patients with stable, treated CNS metastases may be eligible).