NCT05302284

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma
• HER2-expressing

Interventions

Type	Name	Description
DRUG	RC48-ADC	2.0 mg/kg IV every 2 weeks
DRUG	Toripalimab	3.0 mg/kg IV every 2 weeks
DRUG	Gemcitabine	1000mg/m2 IV infusion on Days 1 and 8 of every 3 week cycle
DRUG	Cisplatin	70mg/m2 IV infusion on Day 1 of every 3 week cycle
DRUG	Carboplatin	AUC=4.5, IV infusion on Day 1 of every 3 week cycle

Timeline

• Start date: 2022-06-14
• Primary completion: 2026-12-31
• Completion: 2028-04-30
• First posted: 2022-03-31
• Last updated: 2023-12-18

Locations

2 sites across 1 country: China