drugset / Trial / NCT04294628

Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer

NCT04294628

Phase 1 Active not recruiting 62 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the biological effects of DS-8201a on patients with HER2 positive cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). DS-8201a works by binding to a protein called HER2 that is present on the surface of tumor cells. This allows DS-8201a to kill the tumor cells by damaging their deoxyribonucleic acid (DNA), resulting in tumor cell death. This study looks at how DS-8201a may affect the levels of certain proteins and immune cells in tumors and how well the drug works against tumor cells by examining cells from a small piece tumor taken before and after DS-8201a is given.

Timeline

Start
2020-09-01
Primary completion
2025-09-02
Completion
2027-01-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous