A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer
Other Urinary | Breast | Urinary Bladder
What is the purpose of this trial?
This is a study of DS-8201a, which is an experimental drug not approved yet by the FDA.
Participants will receive this study drug along with a cancer drug that is already being used, 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.
- Ages18 years and older
- Trial withDaiichi Sankyo
- Start Date04/25/2019
- End Date09/29/2020
- Last Updated04/29/2019
- Study HIC#2000023642