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DESTINY-Gastric03: Study of T-DXd Combinations for Advanced HER2-expressing Gastric Cancer

This study, DESTINY-Gastric03, is looking at the safety and effectiveness of a drug called trastuzumab deruxtecan (T-DXd). It's being tested alone or with other treatments like chemotherapy (Fluorouracil, Capecitabine, Oxaliplatin) and immunotherapy (Durvalumab, Trastuzumab). This is for people with advanced gastric (stomach), gastroesophageal junction (where the esophagus meets the stomach), or esophageal cancer that has a specific biomarker called HER2. Researchers want to see if these combinations are safe and if they can shrink tumors. The study plans to enroll about 450 participants, aged 18 and older, who have HER2-positive cancer.

Study design
This is an interventional study with a planned enrollment of 450 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be assessed up to approximately 24 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04379596

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~452 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Fluorouracil (5-FU)CapecitabineDurvalumabOxaliplatinTrastuzumabTrastuzumab deruxtecan

At a glance

Recruiting sites
0 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0
Measured over Safety will be assessed up to the follow-up period, approximately 24 months.
+5 more outcomes measured

Conditions

Gastric Cancer

Explore related trials

Esophageal CarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaERBB2 Gene

Where it's being run

71 sites across 18 states
Russia10
China7
Germany6
Italy6
Brazil5
Poland5
South Korea5
Spain5

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0Safety will be assessed up to the follow-up period, approximately 24 months.

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

  • Part 1: Ocurrence of dose-limiting toxicities (DLTs)Safety will be assessed up to the follow-up period, approximately 24 months.

    Occurrence of dose limiting toxicities

  • Part 1: Changes from baseline in laboratory parametersSafety will be assessed up to the follow-up period, approximately 24 months.

    Changes in laboratory parameters (every in appropriate units) compared to baseline results.

  • Part 1: Changes from baseline in vital signsSafety will be assessed up to the follow-up period, approximately 24 months.

    Changes in vital signs results compared to baseline results.

  • Part 1: Changes from baseline in electrocardiogram (ECG) resultsSafety will be assessed up to the follow-up period, approximately 24 months.

    Changes in ECG results compared to baseline results.

  • Part 2, Part 3, Part 4 and Part 5: Endpoint assessed by Investigator per RECIST v1.1: Confirmed Objective Response Rate (ORR)(Endpoint: ORR) Efficacy will be assessed at an average of approximately 12 months

    Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.