drugset / Trial / NCT07374549

SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma

NCT07374549

Phase 2 Not yet recruiting 100 enrolled CSPC Megalith Biopharmaceutical Co.,Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma. This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.

Timeline

Start
2026-06-20
Primary completion
2028-06-01
Completion
2028-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enfortumab Vedotin Other / unclassified 1.25 mg/kg Intravenous
Comparator SYS6002 Other / unclassified Intravenous

Indications