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)
🩺 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
🧪 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 (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.
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- Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer — Los Angeles, California
- Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer — Baltimore, Maryland
- Study for AZD4360 in Participants With Advanced Solid Tumours — Santa Monica, California
- Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma — Tampa, Florida
Explore by condition: All Gastric Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.