Brief Title: Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

INTRODUCTION

• Org Study ID: DS8201-A-U105
• Secondary ID: 2018-000371-32
• NCT ID: NCT03523572
• Sponsor: Daiichi Sankyo, Inc.

BRIEF SUMMARY

This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019)
for the treatment of HER2-positive unresectable or metastatic breast cancer following two or
more prior anti-HER2 based regimens.

Participants will receive this study drug along with a cancer drug, an immune checkpoint
inhibitor, anti-PD1, called nivolumab.

The study will be done in two parts:

- Part 1 is to identify the recommended dose to use for treatment.

- Part 2 is to find out how well the combination works, and how safe and tolerable it is.

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DETAILED DESCRIPTION

The purpose of this phase 1b (Part 1, Part 2) study is to assess the combination of a test
drug (trastuzumab deruxtecan) with nivolumab 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 test different doses of trastuzumab deruxtecan when given along with a
fixed dose of nivolumab, and establish the most effective and the maximum/recommended
tolerated dose, when used in combination with nivolumab

- Part 2 is to assess the efficacy and safety of this dose combination.

• Overall Status
  Recruiting
• Start Date
  June 20, 2018
• Phase
  Phase 1
• Study Type
  Interventional