🏛️ Verified NIH Record • Updated 2026-03-10

A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (NCT04639219)

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.

Who can join: Review the eligibility criteria below.

Location: Research Site — Santa Rosa, California

Age range: 18 Years to 120 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (30 Sites)

Showing the first 25 of 30 sites.

  • Research Site — Santa Rosa, California
  • Research Site — Muncie, Indiana
  • Research Site — Boston, Massachusetts
  • Research Site — Boston, Massachusetts
  • Research Site — Middletown, New Jersey
  • Research Site — Commack, New York
  • Research Site — Harrison, New York
  • Research Site — New York, New York
  • Research Site — Houston, Texas
  • Research Site — Fairfax, Virginia
  • Research Site — Anderlecht,
  • Research Site — Toronto, CA
  • Research Site — Copenhagen,
  • Research Site — Bordeaux,
  • Research Site — Lyon,
  • Research Site — Villejuif,
  • Research Site — Milan,
  • Research Site — Milan,
  • Research Site — Naples,
  • Research Site — Chūōku,
  • Research Site — Kashiwa,
  • Research Site — Suita-shi,
  • Research Site — Seoul,
  • Research Site — Seoul,
  • Research Site — Seoul,

💰 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.

Explore by condition: All Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast clinical trials

💡 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.
🏛️ View Official NIH Record ↗