NCT07526792

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

A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial of SYS6002 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure of Platinum-based Chemotherapy andPD-(L)1 Inhibitors

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	SYS6002	SYS6002 by intravenous (IV)
DRUG	Investigator's Choice of Chemotherapy	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) ).

Timeline

• Start date: 2026-06-20
• Primary completion: 2029-06-01
• Completion: 2029-12-01
• First posted: 2026-04-13
• Last updated: 2026-04-13