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SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma

NCT07374549 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-29

No results posted yet for this study

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

  • Advanced Urothelial Carcinoma

Interventions

DRUG

SYS6002

SYS6002 by intravenous (IV)

DRUG

enfortumab vedotin

1.25 mg/kg by IV on Day 1、8、15, every 28 days.

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07374549 on ClinicalTrials.gov