This is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of SYS6043 versus investigator's choice chemotherapy in participants with platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer.
Female participants aged ≥ 18 years (as of the date of signed informed consent).
Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a histologic subtype of high-grade serous carcinoma or G2-G3 endometrioid carcinoma.
Participants with prior platinum-based therapy and confirmed platinum-resistant recurrent disease, defined as disease progression or recurrence during platinum-based chemotherapy or within 6 months (183 days) after the last dose of platinum-based chemotherapy. No more than 1 line of systemic therapy following platinum-resistant recurrence, and a total number of treatment lines not exceeding 4 lines.
At least one evaluable extracranial lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Patients with platinum-refractory disease (progression within 1 month after the last platinum-containing therapy).
Prior treatment with B7H3-targeted therapy.
Prior treatment with irinotecan, topotecan, any other topoisomerase I inhibitor (including investigational TOP1 inhibitors), or topoisomerase inhibitor-antibody drug conjugate (e.g., trastuzumab deruxtecan, etc.).
Patients for whom paclitaxel, topotecan, and pegylated liposomal doxorubicin (as listed in the control group) are all considered inappropriate by the investigator.