NCT06079112

9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

A Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.

Conditions

• Advanced Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	9MW2821	1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
DRUG	Toripalimab	240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.

Timeline

• Start date: 2023-09-27
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-10-12
• Last updated: 2024-09-19

Locations

1 site across 1 country: China