Clinical Trial

A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

Recruiting Phase 3
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Summary
This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-03-21; most recent amendment 2023-12-15.
Status change: Not Yet Recruiting → Recruiting 2022-08-22
Trial Details
NCT Number NCT05302284
Lead Sponsor RemeGen Co., Ltd.
Conditions Urothelial Carcinoma, HER2-expressing
Enrollment 452 participants
Start Date 2022-06-14
Primary Completion 2026-12-31 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2023-12-18