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New cocktail of drugs shows promise for tough stomach cancer

NCT ID NCT05702229

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial is testing several new drug combinations in people with advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery or has spread. The study aims to see if these combinations can shrink tumors and keep them from growing for at least 6 months. About 163 participants will receive different combinations of immunotherapy and chemotherapy drugs.

What this could mean

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

Active substance
Rilvegostomig, Volrustomig, FOLFOX, XELOX, AZD0901, 5-Fluorouracil, Capecitabine
What this could lead to
If successful, this could point toward more effective combination treatments for advanced gastric cancer, potentially improving tumor shrinkage and delaying disease progression.
What could go wrong
This is an early Phase 2 trial with a small number of participants, so results may not apply to all patients. The drug combinations may cause significant side effects or fail to show benefit.

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

About 163 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

May 2029

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 years and older

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: * 18 years or older at the time of signing the ICF. * Body weight \> 35 kg. * Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. * Has measurable target disease assessed by the Investigator based on RECIST 1.1. * ECOG PS zero or one. * Life expectancy of at least 12 weeks. * Adequate organ and bone marrow function. * Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 i s open for recruitment. Exclusion Criteria: * Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma. * Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression. * Participants with ascites which cannot be controlled with appropriate interventions. * Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C. * Uncontrolled intercurrent illness. * Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment. * History of another primary malignancy. * Previous treatment with an immune-oncology agent. * Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4 is open for recruitment).

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Gastric cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Los Angeles, California, 90017, United States

  • Research Site

    WITHDRAWN

    Los Angeles, California, 90095, United States

  • Research Site

    RECRUITING

    Baton Rouge, Louisiana, 70817, United States

  • Research Site

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Research Site

    WITHDRAWN

    New Hyde Park, New York, 11042, United States

  • Research Site

    WITHDRAWN

    New York, New York, 10028, United States

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    WITHDRAWN

    New York, New York, 11210, United States

  • Research Site

    WITHDRAWN

    Shirley, New York, 11967, United States

  • Research Site

    WITHDRAWN

    The Bronx, New York, 10469, United States

  • Research Site

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15212, United States

  • Research Site

    RECRUITING

    Beijing, 100142, China

  • Research Site

    RECRUITING

    Hangzhou, 310003, China

  • Research Site

    RECRUITING

    Hangzhou, 310020, China

  • Research Site

    RECRUITING

    Harbin, 150081, China

  • Research Site

    RECRUITING

    Hefei, 230031, China

  • Research Site

    COMPLETED

    Kunming, 650118, China

  • Research Site

    RECRUITING

    Wuhan, 430079, China

  • Research Site

    RECRUITING

    Yinchuan, 750004, China

  • Research Site

    RECRUITING

    Zhengzhou, 450052, China

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Kashiwa, 227-8577, Japan

  • Research Site

    RECRUITING

    Sunto-gun, 411-8777, Japan

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Elche(Alicante), 03202, Spain

  • Research Site

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Research Site

    RECRUITING

    Madrid, 28007, Spain

  • Research Site

    RECRUITING

    Madrid, 28040, Spain

  • Research Site

    RECRUITING

    Santander, 39008, Spain

  • Research Site

    RECRUITING

    Hsinchu, 300, Taiwan

  • Research Site

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Research Site

    RECRUITING

    Taichung, 404, Taiwan

  • Research Site

    RECRUITING

    Tainan, 70403, Taiwan

  • Research Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Research Site

    RECRUITING

    Taipei, 11259, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 333, Taiwan

  • Research Site

    WITHDRAWN

    Edinburgh, EH4 2XU, United Kingdom

  • Research Site

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    RECRUITING

    London, EC1M 6BQ, United Kingdom

  • Research Site

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

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