drugset / Trial / NCT03368196

DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein

NCT03368196

Phase 1 Completed 12 enrolled Daiichi Sankyo AstraZeneca · collab
NaSingle-groupOpen-labelTreatment

Summary

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate. The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with certain types of stomach and breast cancer that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

Timeline

Start
2018-04-02
Primary completion
2018-09-14
Completion
2022-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab deruxtecan Monoclonal antibody Intravenous