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Joint Clinical Trials Office

Pilot Study of DS-8201a Pharmacodynamics in Patients with HER2-expressing Advanced Solid Tumors

Clinical Trial Details

The purpose of this study is to evaluate the study drug, DS-8201a (also known as Enhertu or fam-trastuzumab deruxtecan-nxki) for advanced solid tumors. The study aims to see how DS-8201a affects the levels of certain proteins and immune cells in solid tumors, how well it works against cancer cells, and how safe and tolerable it is.

The United States Food and Drug Administration (FDA) has approved DS-8201a for the treatment of patients with advanced HER2-positive breast or gastric cancer.

Participants will receive DS-8201a intravenously every three weeks. Cells will be examined from a small piece of the tumor taken before DS-8201a is given and after DS-8201a is given. Participants will continue to receive DS-8201a as long as their cancer does not worsen, side effects are tolerable, and they agree to stay in the study.

Key Eligibility: 
  1. Over the age of 18 with a diagnosis of a solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy
  2. Participants must have HER2-positive or HER2-expressing tumors

Detailed eligibility will be reviewed when you contact the study team. 

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Cora Sternberg, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2212025437

ClinicalTrials.gov:

NCT04294628

Sponsor:

10346

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • National Cancer Institute (NCI)

Disease

Cancer
Advanced Solid Tumor
Breast Cancer
Solid Tumors