Description |
A Single-arm, Open-label, Multi-center Phase 2 Study of 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 (EV-203), the main objective is To determine the antitumor activity of single-agent enfortumab vedotin (EV) as measured by confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as determined by independent review committee (IRC), and To assess the PK of antibody-drug conjugate (ADC), total antibody (TAb) and monomethyl auristatin E (MMAE) in Chinese participants with locally advanced or metastatic urothelial cancer. |