๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-25

Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer (NCT04294628)

Pilot Study of DS-8201a Pharmacodynamics in Patients With HER2-Expressing Advanced Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: National Cancer Institute Developmental Therapeutics Clinic โ€” Bethesda, Maryland

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (6 Sites)

  • National Cancer Institute Developmental Therapeutics Clinic โ€” Bethesda, Maryland
  • National Institutes of Health Clinical Center โ€” Bethesda, Maryland
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • NYP/Weill Cornell Medical Center โ€” New York, New York
  • Ohio State University Comprehensive Cancer Center โ€” Columbus, Ohio
  • University of Pittsburgh Cancer Institute (UPCI) โ€” Pittsburgh, Pennsylvania

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—