Spots Global Cancer Trial Database for A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

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Trial Identification

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

Official Title: A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing

Study ID: NCT05302284

Conditions

Urothelial Carcinoma

HER2-expressing

Interventions

Study Description

Brief 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.

Detailed Description: This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study to evaluate the efficacy and safety of RC48-ADC,a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in Combination With JS001,a PD-1 monoclonal antibody, for the treatment of Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.