Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (NCT05372614)
Phase I Trial of DS-8201a (Trastuzumab Deruxtecan) in Combination With Neratinib in Solid Tumors With HER2 Alterations
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial tests the safety, side effects, and best dose of neratinib in combination with trastuzumab deruxtecan in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable), and have changes in a gene called human epidermal growth factor receptor 2 (HER2). Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Adding neratinib to trastuzumab deruxtecan may be able to shrink cancer with a change in the HER2 gene.
Who can join: Review the eligibility criteria below.
Location: City of Hope Comprehensive Cancer Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- City of Hope Comprehensive Cancer Center — Duarte, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- City of Hope at Irvine Lennar — Irvine, California
- City of Hope Antelope Valley — Lancaster, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- City of Hope South Pasadena — South Pasadena, California
- City of Hope Upland — Upland, California
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Northwestern University — Chicago, Illinois
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Washington University School of Medicine — St Louis, Missouri
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- UT MD Anderson Cancer Center — Houston, Texas
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Email: becomingapatient@coh.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
More studies in Metastatic Malignant Solid Neoplasm
- Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial — Birmingham, Alabama
- Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors — Houston, Texas
- Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors — Boston, Massachusetts
- Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and CXCL13 Expression — Houston, Texas
- Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer — Phoenix, Arizona
- Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors — Sacramento, California
Explore by condition: All Metastatic Malignant Solid Neoplasm clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.