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

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NCT04379596 · readout in 286 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.

Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
450estimated
Sites
100
Countries
Brazil, Canada, China +11

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-06-03actualWhen the study began enrolling
Primary completion2027-06-01estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-06-01estimatedThe whole study's end, after follow-up
First posted2020-05-07actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-10actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Gastric Cancer

Interventions

  • Drug: Fluorouracil (5-FU)
  • Drug: Capecitabine
  • Biological: Durvalumab — also filed as MEDI4736
  • Drug: Oxaliplatin
  • Biological: Trastuzumab
  • Drug: Trastuzumab deruxtecan — also filed as DS-8201a, Enhertu
  • Drug: Cisplatin
  • Biological: Pembrolizumab
  • Biological: Volrustomig — also filed as MEDI5752
  • Biological: Rilvegostomig — also filed as AZD2936

Primary outcomes

what the primary-completion date above is the date OF
Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0
measured Safety will be assessed up to the follow-up period, approximately 24 months.
Part 1: Ocurrence of dose-limiting toxicities (DLTs)
measured Safety will be assessed up to the follow-up period, approximately 24 months.
Part 1: Changes from baseline in laboratory parameters
measured Safety will be assessed up to the follow-up period, approximately 24 months.
Part 1: Changes from baseline in vital signs
measured Safety will be assessed up to the follow-up period, approximately 24 months.
Part 1: Changes from baseline in electrocardiogram (ECG) results
measured Safety will be assessed up to the follow-up period, approximately 24 months.
Part 2, Part 3, Part 4 and Part 5: Endpoint assessed by Investigator per RECIST v1.1: Confirmed Objective Response Rate (ORR)
measured (Endpoint: ORR) Efficacy will be assessed at an average of approximately 12 months

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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