This is a study of trastuzumab deruxtecan 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03523572.
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 maximum tolerated dose/recommended dose
for expansion, when used in combination with nivolumab
- Part 2 is to assess the efficacy and safety of this dose combination.
Lead OrganizationDaiichi Sankyo Inc
