drugset / Trial / NCT07526792

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

NCT07526792

Phase 3 Not yet recruiting 406 enrolled CSPC Megalith Biopharmaceutical Co.,Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2026-06-20
Primary completion
2029-06-01
Completion
2029-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject SYS6002 Other / unclassified Intravenous

Indications