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ACTIVE NOT RECRUITINGPhase2

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

Sponsor: AstraZeneca

NCT ID: NCT04379596

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Fluorouracil (5-FU) (drug), Capecitabine (drug), Durvalumab (biological), Oxaliplatin (drug)
How long the study runs
Study runs about 83 months (dates as stated)
About the drug or intervention
Fluorouracil (5-FU) — drug: 5-FU: administered as an IV infusion · Capecitabine — drug: Capecitabine: administered orally · Durvalumab — biological: Durvalumab: administered as an IV infusion · Oxaliplatin — drug: Oxaliplatin: administered as an IV infusion · Trastuzumab — biological: Trastuzumab: administered as an IV infusion · Trastuzumab deruxtecan — drug: T-DXd: administered as an IV infusion · Cisplatin — drug: Cisplatin: administered as an IV infusion · Pembrolizumab — biological: Pembrolizumab: administered as an IV infusion · Volrustomig — biological: Volrustomig: administered as an IV infusion · Rilvegostomig — biological: Rilvegostomig: administered as an IV infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how safe and useful combinations of a drug called T-DXd are for people with advanced stomach cancer, including cancer where it cannot be removed by surgery or has spread. The trial has different parts: some for people whose cancer has high levels of a protein called HER2, and some for people with lower levels. It is run by AstraZeneca.

Who can take part

  • Adults aged 18 or over (other age rules may apply locally)
  • Advanced stomach or food-pipe cancer (adenocarcinoma of the stomach, gastro-oesophageal junction, or oesophagus) that cannot be removed by surgery or has spread
  • Cancer tissue tests showing either HER2-positive or HER2-low, depending on the trial part
  • Some parts need prior treatment with trastuzumab; other parts are for people not yet treated for cancer that has spread
  • Measurable disease on scans, judged by the study doctor
  • Good enough bone marrow, heart, kidney and liver function as set out in the study plan
  • If you could have children, you must use highly effective contraception or avoid sex during and after the study

Who may not be able to

  • HIV, hepatitis B or hepatitis C infections (rules differ by trial part)
  • Other serious illness that is not under control
  • Current or past inflammation or scarring of the lungs (pneumonitis or interstitial lung disease), or suspected cases that cannot be ruled out by scans
  • Serious lung illnesses
  • Infection needing treatment through a drip (into a vein)
  • Fluid build-up around the lungs, in the tummy, or around the heart that needs draining, a shunt, or reinfusion therapy
  • Spinal cord compression or active cancer spread to the brain or spinal cord that is causing symptoms

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 130 Years
Who
All
Number of participants
452
Started
2020-06-03
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for gastric cancer
  • • Phase2 - 452 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 130 Years
  • • Diagnosed with gastric cancer

Where?

  • • Cambridge - Research Site
  • • Dundee - Research Site
  • • London - Research Site
  • • Manchester - Research Site
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Gastric Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 130 Years
  • Who can join: All genders

Biomarkers mentioned

HER2

What the study is looking for

  • ✓Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
  • ✓Disease Characteristics:
  • ✓that has grown locally, unresectable, or that has spread disease based on most recent imaging
  • ✓For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+...
  • ✓For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC...

Who cannot take part

  • ✗Uncontrolled intercurrent illness.
  • ✗History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging...
  • ✗Lung-specific intercurrent clinically significant severe illnesses.
  • ✗Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
  • ✗Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and...
See the full criteria
Inclusion criteria: 1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations 2. Disease Characteristics: 1. Locally advanced, unresectable, or metastatic disease based on most recent imaging 2. For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results 3. For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results 3. For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3, Part 4 and Part 5, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/ esophagus with with HER2-positive (Part 2 and Part 3 \[Arm 3A\] and Part 4 \[Arm 4A\]) or HER2-low (Part 3 \[Arm 3B\], Part 4 \[Arm 4B\] and Part 5)) status 4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1 5. Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function 6. If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study. Exclusion criteria: 1. Part 1 to 4: History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection. Part 5: evidence of active, uncontroled HIV, HBV or HCV infection. 2. Uncontrolled intercurrent illness. 3. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening. 4. Lung-specific intercurrent clinically significant severe illnesses. 5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. 6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). 7. Has spinal cord compression or clinically active central nervous system metastases.

Where Is This Study? (5 UK sites)

Research Site

Cambridge CB2 0QQ, United Kingdom

Research Site

Dundee DD1 9SY, United Kingdom

Research Site

London NW1 2PG, United Kingdom

Research Site

Manchester M20 4BX, United Kingdom

Research Site

Sutton SM2 5PT, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08