๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer (NCT04585958)

A Phase I Study of DS-8201a in Combination With Olaparib in HER2-Expressing Malignancies

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

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

This phase I trial identifies the side effects and best dose of DS-8201a and olaparib in treating patients with HER2-expressing cancers that have spread to other places in the body or cannot be removed by surgery or ovarian cancer that remains despite treatment with a platinum treatment (platinum resistant). DS-8201a is an antibody-drug conjugate. This agent has two components: an antibody component and a chemotherapy component. The antibody component is attached to the chemotherapy molecules. Upon administration of DS-8201a, the antibody targets and binds to tumor cells that have abundant HER2 (human-epidermal growth factor receptor 2), which is a protein on the surface of some tumor cells. The chemotherapy then enters the cells and blocks deoxyribonucleic acid (DNA) replication in the tumor cells with abundant HER2, causing them to die. Olaparib is a drug that blocks an enzyme involved in many cell functions, including the repair of DNA damage. Blocking this enzyme may help keep tumor cells from repairing their damaged DNA, causing them to die. Giving DS-8201a and olaparib may shrink or stabilize the cancer.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Hospital in Arizona โ€” Phoenix, Arizona

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 (13 Sites)

  • Mayo Clinic Hospital in Arizona โ€” Phoenix, Arizona
  • UM Sylvester Comprehensive Cancer Center at Coral Gables โ€” Coral Gables, Florida
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach โ€” Deerfield Beach, Florida
  • UM Sylvester Comprehensive Cancer Center at Doral โ€” Doral, Florida
  • Mayo Clinic in Florida โ€” Jacksonville, Florida
  • University of Miami Miller School of Medicine-Sylvester Cancer Center โ€” Miami, Florida
  • UM Sylvester Comprehensive Cancer Center at Kendall โ€” Miami, Florida
  • UM Sylvester Comprehensive Cancer Center at Plantation โ€” Plantation, Florida
  • Emory University Hospital Midtown โ€” Atlanta, Georgia
  • Emory University Hospital/Winship Cancer Institute โ€” Atlanta, Georgia
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • Mayo Clinic in Rochester โ€” Rochester, Minnesota
  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 664-4580

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

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. Contact the study coordinator using the phone/email above.
  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†—