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. A total number of treatment lines not exceeding 5 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.
Parallel
SYS6043
DrugParticipants in the experimental group will receive SYS6043, administered on Day 1 of each cycle.
Liposomal doxorubicin, paclitaxel, or topotecan
DrugParticipants in the control group will receive investigator's choice chemotherapy: Liposomal doxorubicin 40 mg/m² every 28 days (Q4W), administered on Day 1 of each cycle; Paclitaxel 80 mg/m² every 28 days (Q4W), administered on Days 1, 8, 15, and 22 of each cycle; Topotecan 4 mg/m² every 28 days (Q4W), administered on Days 1, 8, and 15 of each cycle.
Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
Overall Survival
Time from randomization to the date of death due to any cause.
ORR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
DoR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
PFS by the investigator based on RECIST v1.1.
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