SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07526792
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • SYS6002 — DRUG
    SYS6002 by intravenous (IV)
  • Investigator's Choice of Chemotherapy — DRUG
    Investigator's choice of chemotherapy means the chemotherapy chosen by investigators to treat urothelial carcinoma including docetaxel (75 mg/m\^2 by IV on Day 1, every 21 days),paclitaxel (175 mg/m\^2 by IV on Day 1, every 21 days)or pemetrexed (500 mg/m\^2 by IV on Day 1, every 21 days) ).

Study Details

This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy,safety PK characteristics, and immunogenicity of SYS6002 compared with chemotherapy in participants with locally advanced or metastatic urothelial carcinoma. This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will commence only after formal approval is obtained from the relevant Ethics Committee).

Key Dates

First listed
Apr 13, 2026
Start date
Jun 20, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2029
Completion
Dec 1, 2029

Study Design

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

Arms

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

Primary Outcome Measure

Overall Survival [ Time Frame: Up to approximately 3 years ]

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