Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
NCT04379596 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Capecitabine
- BIOLOGICAL Durvalumab
- DRUG Oxaliplatin
- DRUG Fluorouracil (5-FU)
- BIOLOGICAL Trastuzumab
Study Locations (20)
Other
- Research Site — Florianópolis
- Research Site — Londrina
- Research Site — Natal
- Research Site — Porto Alegre
- Research Site — Ribeirão Preto
- Research Site — Rio de Janeiro
- Research Site — Santa Maria
- Research Site — São Jose Do Rio Preto
- Research Site — São Paulo
- Research Site — São Paulo
Massachusetts
- Research Site — Boston
- Research Site — Boston
California
- Research Site — Santa Monica
Kansas
- Research Site — Westwood
Maryland
- Research Site — Baltimore
Michigan
- Research Site — Ann Arbor
New York
- Research Site — New York
North Carolina
- Research Site — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2020-06-03 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04379596
The ClinicalTrials.gov registry entry for NCT04379596 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04379596 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Massachusetts, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04379596 about?
NCT04379596 is a clinical study titled "Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)". 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 ...
What is the current status of trial NCT04379596?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 450 participants. The study started on 2020-06-03. Estimated completion is 2027-06-01.
What conditions does trial NCT04379596 study?
This clinical trial studies the following conditions: Gastric Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04379596?
The interventions under investigation include: Capecitabine (DRUG), Durvalumab (BIOLOGICAL), Oxaliplatin (DRUG), Fluorouracil (5-FU) (DRUG), Trastuzumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04379596?
This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04379596 being conducted?
This trial has 20 study locations across California, Kansas, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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