NCT06196736

A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer

An Open-label, Randomized Phase 3 Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Have Previously Received PD-(L)1 Inhibitor and Platinum-containing Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.

Conditions

• Advanced Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	9MW2821	1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle
DRUG	Chemotherapy	75mg/m\^2 docetaxel by intravenous infusion or 175 mg/m\^2 paclitaxel by intravenous infusion on day 1 of every 21-day cycle.

Timeline

• Start date: 2023-12-29
• Primary completion: 2026-09-01
• Completion: 2027-07-01
• First posted: 2024-01-09
• Last updated: 2025-04-13

Locations

1 site across 1 country: China