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Clinical Trial Summary

The purpose of this phase 1b study is to test the combination of an experimental drug known as DS-8201a given along with Nivolumab (a marketed drug) in participants with HER2-expressing breast and urothelial cancer who had disease progression during or after prior therapies, did not respond to standard therapies, or for whom no standard therapy is available.

The study will be performed in 2 parts.

- Part 1 is to look at different doses of DS-8201a when given along with a fixed dose of nivolumab, and establish the most effective and safe dose (maximum/recommended tolerated dose) when used in combination with nivolumab.

- Part 2 is to understand the positive or negative effects of this dose combination on the participant's body and disease.

The study will also determine the pharmacokinetics of DS-8201a when administered with nivolumab.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03523572
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Recruiting
Phase Phase 1
Start date June 20, 2018
Completion date September 2020

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