Accession PRJCA014229
Title A Phase 2 Study of Enfortumab Vedotin (ASG-22CE) in Chinese Subjects Who Previously Received Platinum-containing Chemotherapy and PD-1/PD-L1 Inhibitor Therapy
Relevance Medical
Data types PK Data, Image Data
Organisms Homo sapiens
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.
Sample scope Multiisolate
Release date 2023-01-05
Grants
Agency program Grant ID Grant title
No funding support
Submitter Jun Guo (guoj307@126.com)
Organization Beijing Cancer Hospital
Submission date 2023-01-05

Project Data

Resource name Description