NCT06551233

Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)

A Clinical Study on the Safety and Efficacy of 9MW2821 in Patients With High-risk Non-muscle-invasive Bladder Cancer (NMIBC) That Have Previously Failed to Intravesical Therapy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	9MW2821	Patients will be evaluated from low dose to high dose through intravesical therapy and then select the suitable doses to expand according to study data.

Timeline

• Start date: 2024-04-22
• Primary completion: 2024-11-30
• Completion: 2025-12-31
• First posted: 2024-08-13
• Last updated: 2024-08-13

Locations

1 site across 1 country: China