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New hope for stomach cancer: targeted drug combo trial launches

NCT ID NCT04379596

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests a drug called trastuzumab deruxtecan (T-DXd), alone or with chemotherapy and immunotherapy, in people with advanced HER2-positive stomach or esophageal cancer. The goal is to see if these combinations are safe and can shrink tumors. About 450 adults with cancer that has spread or cannot be removed by surgery will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trastuzumab deruxtecan (Enhertu) alone or with chemotherapy and/or immunotherapy
What this could lead to
If successful, this could provide a new treatment option for people with advanced HER2-positive gastric cancer, potentially shrinking tumors and delaying disease progression.
What could go wrong
This is an early-phase trial (Phase 1b/2) with a small number of participants, so results may not apply to all patients. Side effects from the drug combinations could be serious, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

452 people

The number who actually took part.

Started

Jun 2020

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma carcinoma esophageal adenocarcinoma Esophageal Neoplasms gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer

Contacts and locations

Locations

  • Research Site

    Baltimore, Maryland, 21287, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Houston, Texas, 77090, United States

  • Research Site

    Londrina, 86015-520, Brazil

  • Research Site

    Ribeirão Preto, 14051-140, Brazil

  • Research Site

    Santa Maria, 97015-450, Brazil

  • Research Site

    São Jose Do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 045202-001, Brazil

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    Québec, Quebec, G1J 1Z4, Canada

  • Research Site

    Chengdu, 610042, China

  • Research Site

    Guangzhou, 510062, China

  • Research Site

    Hefei, 230001, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 110001, China

  • Research Site

    Wuhan, 430000, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Frankfurt, 60488, Germany

  • Research Site

    Frankfurt, 60590, Germany

  • Research Site

    Hamburg, 20249, Germany

  • Research Site

    Leipzig, 04103, Germany

  • Research Site

    Mannheim, 68167, Germany

  • Research Site

    München, 81675, Germany

  • Research Site

    Milan, 20133, Italy

  • Research Site

    Milan, 20162, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    Verona, 37134, Italy

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Amsterdam, 1066CX, Netherlands

  • Research Site

    Amsterdam, 1081 HV, Netherlands

  • Research Site

    Utrecht, 3584CG, Netherlands

  • Research Site

    Gdansk, 80-214, Poland

  • Research Site

    Konin, 62-500, Poland

  • Research Site

    Koszalin, 75-581, Poland

  • Research Site

    Krakow, 31-501, Poland

  • Research Site

    Warsaw, 02-034, Poland

  • Research Site

    Kostroma, 156005, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 125284, Russia

  • Research Site

    Moscow, 143423, Russia

  • Research Site

    Moscow, 143442, Russia

  • Research Site

    Novosibirsk, 630099, Russia

  • Research Site

    Saint Petersburg, 195271, Russia

  • Research Site

    Saint Petersburg, 196603, Russia

  • Research Site

    Saint Petersburg, 197022, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Kaohsiung City, 80756, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • 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

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