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NCT04379596 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Gastric Cancer, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 2
Development phase
450
Enrollment target
20
Study locations

NCT04379596: Recruiting Phase 2 study of Gastric Cancer, sponsored by AstraZeneca.

NCT04379596 is a Phase 2 study of Gastric Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 450 participants, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04379596, a Phase 2 study of Gastric Cancer, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 2
Development phase
450 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0

Conditions Studied

Gastric Cancer

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

FieldValue
Enrollment Target 450 participants
Start Date 2020-06-03
Est. Completion 2027-06-01
Phase Phase 2
AstraZeneca

1,285 total trials

What NCT04379596 shows while recruiting

NCT04379596 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (42% higher).

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.

NCT04379596 names 20 study sites across 10 states, led by Other, Massachusetts, California.

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.

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).

Who is sponsoring clinical trial NCT04379596?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Gastric Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04379596's enrollment target sits among peer trials

450 29th of 153 higher than 124 of 153 other Gastric Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gastric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04379596

Source: ClinicalTrials.gov NCT04379596, the US trial registry maintained by the National Library of Medicine. NCT04379596 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.