SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07230626
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SYS6002 — DRUG
    SYS6002，intravenous injection
  • Investigator's Choice of Chemotherapy — DRUG
    Investigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat metastatic cervical cancer, including topotecan (1.2 mg/m\^2 of by IV on Days 1 to 5, every 21 days), gemcitabine (1000 mg/m\^2 by IV on Days 1 and 8, every 21 days), pemetrexed (500 mg/m\^2 by IV on Day 1, every 21 days), or docetaxel (75 mg/m\^2 by IV on Day 1, every 21 days).

Study Details

This study is a randomized, open-label, controlled, multicenter phase Ⅲ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy and PD-1/L1 inhibitor therapy

Key Dates

First listed
Nov 17, 2025
Start date
Nov 20, 2025
Status verified
Nov 2025
Primary completion
Jan 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
412 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6002
    SYS6002 monotherapy
  • Active Comparator: Chemotherapy
    Investigator's choice of one chemotherapy treatment (topotecan, gemcitabine, pemetrexed, or docetaxel)

Primary Outcome Measure

Overall Survival [ Time Frame: Up to 3.5 years ]

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