NCT06592326

9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.

Detailed description

The study is planning to enroll approximately 460 participants with unresectable locally advanced or metastatic urothelial cancer who have not previously received systematic treatment.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	9MW2821	9MW2821, 1.25mg/kg, intravenous (IV) infusion
DRUG	Toripalimab	Toripalimab, 240mg, intravenous (IV) infusion
DRUG	Gemcitabine	Gemcitabine: 1000mg/m2, intravenous (IV) infusion
DRUG	Cisplatin/Carboplatin	Cisplatin: 70mg/m2 or Carboplatin: AUC=4.5/5, intravenous (IV) infusion.

Timeline

• Start date: 2024-08-22
• Primary completion: 2027-09-01
• Completion: 2028-12-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China