A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and PD 1/PD-L1 Inhibitor Therapy

• Status: Recruiting
• Trial end date: 2024-05-31

Summary

The purpose of this study is to determine the antitumor activity of enfortumab vedotin (EV) confirmed by the objective response rate (ORR).

This study will also evaluate the effect of antibody-drug conjugate (ADC), total antibody (TAb) and monomethyl auristatin E (MMAE) in Chinese participants with locally advanced or metastatic urothelial cancer.

In addition, the study will also evaluate the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and immunogenicity determined by the incidence of antitherapeutic antibodies (ATA).

Safety and tolerability of EV in participants with locally advanced or metastatic urothelial cancer will also be evaluated.

• Phase: Phase 2

Details

• Lead Sponsor: Astellas Pharma China, Inc.
• Collaborator: Seagen Inc.