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SYS6043 vs Chemotherapy in Platinum-resistant Advanced Ovarian Cancer
NCT07708753Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2026
- Primary completion
- Oct 2029
- Countries
- 1
- Drugs
- SYS6043
- Conditions
- ovarian cancerprimary peritoneal cancer (PPC)fallopian tube cancer (PFTC)
01
Overview
Phase 3, randomised, open-label trial of SYS6043 in ovarian cancer, primary peritoneal cancer (PPC) and fallopian tube cancer (PFTC) (2 arms), sponsored by CSPC Megalith Biopharmaceutical Co., Ltd. Primary endpoints: Progression-Free Survival by Blinded Independent Central Review (BICR) at 16 months and Overall Survival at 39 months. Started Jul 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Experimental Arm
SYS6043 administered on Day 1 of each cycle.
Active Comparator Arm
Investigator's choice chemotherapy (liposomal doxorubicin, paclitaxel, or topotecan).
03
Who it enrols
Female patients >= 18 years with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (high-grade serous or G2-G3 endometrioid), 1-5 prior lines of therapy, ECOG 0-1, and adequate organ function.
04
Endpoints
Primary
Progression-Free Survival by Blinded Independent Central Review (BICR)
Overall Survival
Secondary
Objective Response Rate by Blinded Independent Central Review (BICR)
Duration of Response by Blinded Independent Central Review (BICR)
Disease Control Rate by Blinded Independent Central Review (BICR)
Progression-Free Survival by the investigator
Objective Response Rate by the investigator
Duration of Response by the investigator
Disease Control Rate by the investigator
CA-125 response rate assessed by the investigator
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