🏛️ Verified NIH Record • Updated 2026-08-27

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (NCT04379596)

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

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

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

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.

Who can join: Review the eligibility criteria below.

Location: Research Site — Baltimore, Maryland

Age range: 18 Years to 130 Years

📋 "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 (71 Sites)

Showing the first 25 of 71 sites.

  • Research Site — Baltimore, Maryland
  • Research Site — Boston, Massachusetts
  • Research Site — New York, New York
  • Research Site — Houston, Texas
  • Research Site — Londrina,
  • Research Site — Ribeirão Preto,
  • Research Site — Santa Maria,
  • Research Site — São Jose Do Rio Preto,
  • Research Site — São Paulo,
  • Research Site — Toronto, Ontario
  • Research Site — Montreal, Quebec
  • Research Site — Québec, Quebec
  • Research Site — Chengdu,
  • Research Site — Guangzhou,
  • Research Site — Hefei,
  • Research Site — Shanghai,
  • Research Site — Shenyang,
  • Research Site — Wuhan,
  • Research Site — Zhengzhou,
  • Research Site — Frankfurt,
  • Research Site — Frankfurt,
  • Research Site — Hamburg,
  • Research Site — Leipzig,
  • Research Site — Mannheim,
  • Research Site — München,

💰 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 Gastric Cancer 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 ↗