A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer

Conditions

• Ovarian Cancer
• Recurrent Ovarian Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SYS6041, bevacizumab — DRUG
  SYS6041: RP2D dose, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
• SYS6041, carboplatin, bevacizumab — DRUG
  SYS6041: RP2D dose, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
• paclitaxel, carboplatin, bevacizumab — DRUG
  Paclitaxel:175mg/m2, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
• SYS6041, enlonstobart, bevacizumab — DRUG
  SYS6041: 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 13, 2026

Status verified

Aug 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
• Experimental: 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 officer
  031169085587
  [email protected]
• Xiaohua Wu
  +86 21-13601772486
  [email protected]

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