Overview

A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Status:
Completed
Trial end date:
2019-02-25
Target enrollment:
Participant gender:
Summary
The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.
Phase:
Phase 1
Details
Lead Sponsor:
Astellas Pharma Inc
Collaborators:
Seagen Inc.
Seattle Genetics, Inc.