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

Phase 3 Recruiting 452 enrolled RemeGen Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2022-06-14
Primary completion: 2026-12-31
Completion: 2028-04-30

Publications

Sheng X, Zeng G, Zhang C, Zhang Q, Bian J, Niu H, Li J, Shi Y, Yao K, Hu B, Liu Z, Liao H, Yu Z, Jin B, Zhao P, Yang T, Liu X, Qin Y, Xue X, Gou X, Huang J, Gu J, Qi X, Zhang L, Ma G, Liu B, Fang J, Jiang S, He Z, Zhou A, Guo J; RC48-C016 Trial Investigators. Disitamab Vedotin plus Toripalimab in HER2-Expressing Advanced Urothelial Cancer. N Engl J Med. 2025 Dec 11;393(23):2324-2337. doi: 10.1056/NEJMoa2511648. Epub 2025 Oct 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	—	Intravenous
Comparator	Cisplatin	Other / unclassified	70 mg/m2	Intravenous
Subject	Disitamab Vedotin	Monoclonal antibody	2 mg/kg	Intravenous
Comparator	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Toripalimab	Monoclonal antibody	3 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications