A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Study ID
- NCT07714668
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Ovarian Cancer
- Recurrent Ovarian Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SYS6041, bevacizumab — DRUGSYS6041: RP2D dose, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
- SYS6041, carboplatin, bevacizumab — DRUGSYS6041: RP2D dose, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
- paclitaxel, carboplatin, bevacizumab — DRUGPaclitaxel:175mg/m2, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
- SYS6041, enlonstobart, bevacizumab — DRUGSYS6041: RP2D dose, ivgtt, Q3W Enlonstobart:360mg, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
Study Details
This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.
Key Dates
- First listed
- Jul 20, 2026
- Start date
- Aug 31, 2026
- Status verified
- Jul 2026
- Primary completion
- Apr 30, 2028
- Completion
- Aug 31, 2029
Study Design
- Enrollment
- 171 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SYS6041, bevacizumab
- Experimental: SYS6041, carboplatin, bevacizumab
- Active Comparator: paclitaxel, carboplatin, bevacizumab
- Active Comparator: SYS6041, enlonstobart, bevacizumab
Primary Outcome Measure
The incidence of dose-limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
Central Contacts
- Clinical Trials Information Group officer031169085587
- Xiaohua Wu+86 21-13601772486
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