At a glance
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Pilot Study of DS-8201a Pharmacodynamics in Patients With HER2-Expressing Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 5 other interventions for Advanced Malignant Solid Neoplasm and 3 related conditions. Active but no longer recruiting, targeting 62 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
Undergo biopsy
Undergo collection of blood samples
Undergo CT scan
Undergo ECHO
Undergo MRI
Undergo MUGA
Given IV