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Not Yet RecruitingNCT07374549

SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma

A Randomized, Open-Label, Controlled, Multicenter Phase 2 Trial of SYS6002 Versus PADCEV in Patients With Advanced Urothelial Carcinoma

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSYS6002SYS6002 by intravenous (IV)
DRUGenfortumab vedotin1.25 mg/kg by IV on Day 1、8、15, every 28 days.

Timeline

Start date
2026-06-20
Primary completion
2028-06-01
Completion
2028-12-01
First posted
2026-01-29
Last updated
2026-01-29

Source: ClinicalTrials.gov record NCT07374549. Inclusion in this directory is not an endorsement.

SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma (NCT07374549) · Clinical Trials Directory