New targeted therapy combo aims to fight stubborn stomach cancers

NCT ID NCT07431281

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This Phase 3 trial is testing whether a new targeted drug called sonesitatug vedotin, combined with chemotherapy (capecitabine) and possibly an immunotherapy (rilvegostomig), can help people with advanced stomach, gastroesophageal junction, or esophageal cancer that has a specific marker (CLDN18.2) and is HER2-negative. About 2130 participants will be enrolled to see if the treatment improves survival and delays cancer growth. The study is currently recruiting.

What this could mean

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

Active substance: sonesitatug vedotin (a targeted drug) combined with capecitabine (chemotherapy), with or without rilvegostomig (an immunotherapy)
What this could lead to: If successful, this could provide a new first-line treatment option for people with a specific type of advanced stomach cancer, potentially improving how long they live without their cancer growing.
What could go wrong: This is a large Phase 3 trial, but the drugs are still experimental. Side effects from chemotherapy and targeted therapy are possible, and the combination may not prove more effective than existing treatments.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,130 people

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

Started

Feb 2026

Expected to finish

Oct 2031

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: * Capable of giving signed informed consent * Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. * Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma * Positive CLDN18.2 expression, as determined prospectively by central IHC testing * Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below: 1. Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement. 2. Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible * ECOG performance status of 0 or 1 with no deterioration to \> 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation. * Minimum life expectancy of ≥ 12 weeks. * At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1. * Adequate organ and bone marrow function as specified in the protocol * Body weight ≥ 35 kg. * Sex and contraceptive requirements Exclusion Criteria: * Known HER2-positive status * Significant or unstable gastric bleeding and/or untreated gastric ulcers. * Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded. * CNS pathology * Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain. * Require parenteral nutrition support due to gastric or gastrointestinal obstruction. * Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening. * Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline. * Cardiac abnormalities as outlined in the protocol * Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation. * Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled * Known partial or total DPD enzyme deficiency

Get updates

Get notified about this study

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Conditions

The condition(s) this trial relates to.

adenocarcinoma Adenocarcinoma Of Esophagus esophageal adenocarcinoma esophageal cancer 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.

Esophageal cancer Gastric cancer Gastroesophageal junction adenocarcinoma

How to take part

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

The places running it

284 sites in 23 countries. The list below names each one and where it is.
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 ↗
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

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Birmingham, Alabama, 35294-3300, United States
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Mobile, Alabama, 36604, United States
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Anchorage, Alaska, 99508, United States
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Phoenix, Arizona, 85054, United States
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Springdale, Arkansas, 72762, United States
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Duarte, California, 91010, United States
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Fountain Valley, California, 92708, United States
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Fullerton, California, 92835, United States
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Irvine, California, 92612, United States
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La Jolla, California, 92093, United States
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Los Alamitos, California, 90720, United States
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Orange, California, 92868, United States
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Walnut Creek, California, 94598, United States
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Denver, Colorado, 80210, United States
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Lone Tree, Colorado, 80124, United States
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New Haven, Connecticut, 06510, United States
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Newark, Delaware, 19713, United States
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Washington D.C., District of Columbia, 20007, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32224, United States
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Orlando, Florida, 32806, United States
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St. Petersburg, Florida, 33705, United States
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West Palm Beach, Florida, 33401, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30322, United States
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Atlanta, Georgia, 30342, United States
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Macon, Georgia, 31201, United States
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Newnan, Georgia, 30265, United States
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Chicago, Illinois, 60637, United States
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Niles, Illinois, 60714, United States
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Zion, Illinois, 60099, United States
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Indianapolis, Indiana, 46260, United States
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Waukee, Iowa, 50263, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40217, United States
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Silver Spring, Maryland, 20910, United States
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Boston, Massachusetts, 02114, United States
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Burlington, Massachusetts, 01803, United States
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Worcester, Massachusetts, 01655, United States
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Grand Rapids, Michigan, 49503, United States
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Burnsville, Minnesota, 55337, United States
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Duluth, Minnesota, 55805, United States
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Minneapolis, Minnesota, 55455, United States
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Rochester, Minnesota, 55905, United States
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Kansas City, Missouri, 64132, United States
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St Louis, Missouri, 63110, United States
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Camden, New Jersey, 08103, United States
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East Brunswick, New Jersey, 08816, United States
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Hackensack, New Jersey, 07601, United States
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New Brunswick, New Jersey, 08901, United States
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Summit, New Jersey, 07901, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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New York, New York, 10065, United States
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The Bronx, New York, 10461, United States
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The Bronx, New York, 10468, United States
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White Plains, New York, 10601, United States
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Charlotte, North Carolina, 28204, United States
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Wilmington, North Carolina, 28403, United States
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Winston-Salem, North Carolina, 27103, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43221, United States
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Portland, Oregon, 97213, United States
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Portland, Oregon, 97239, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Pittsburgh, Pennsylvania, 15240, United States
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Wilkes-Barre, Pennsylvania, 18711, United States
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York, Pennsylvania, 17403, United States
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Providence, Rhode Island, 02903, United States
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Charleston, South Carolina, 29425, United States
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Sioux Falls, South Dakota, 57105, United States
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Yankton, South Dakota, 57078, United States
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Memphis, Tennessee, 38104, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75235, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77030, United States
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Sherman, Texas, 75090, United States
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Blacksburg, Virginia, 24060, United States
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Fairfax, Virginia, 22031, United States
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Falls Church, Virginia, 22042, United States
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Fort Belvoir, Virginia, 22060, United States
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Richmond, Virginia, 23219, United States
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Edmonds, Washington, 98026, United States
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Issaquah, Washington, 98029, United States
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Olympia, Washington, 98502, United States
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Seattle, Washington, 98104, United States
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Charleston, West Virginia, 25315, United States
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Milwaukee, Wisconsin, 53226, United States
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Darlinghurst, 2010, Australia
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Garran, 2605, Australia
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Heidelberg, 3084, Australia
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Murdoch, 6150, Australia
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Randwick, 2031, Australia
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Westmead, 2145, Australia
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Woolloongabba, 4102, Australia
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Linz, 4010, Austria
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Rankweil, 6830, Austria
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Vienna, 1090, Austria
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Wiener Neustadt, 2700, Austria
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Barretos, 14784-400, Brazil
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Fortaleza, 60336-045, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 91350200, Brazil
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Salvador, 41.950-610, Brazil
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Santa Maria, 97015-450, Brazil
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São Paulo, 01246-000, Brazil
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Vitória, 29043-260, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Abbotsford British Columbia, British Columbia, V2S0C2, Canada
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Vancouver, British Columbia, VSZ 4E6, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Moncton, New Brunswick, E1C 2Z3, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Sault Ste. Marie, Ontario, P6A 0A8, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Beijing, 100032, China
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Beijing, 100050, China
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Beijing, 100142, China
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Beijing, 102200, China
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Changde, 415000, China
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Chengdu, 610041, China
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Chengdu, 610041, China
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Chongqing, 400016, China
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Fuzhou, 350005, China
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Fuzhou, 350011, China
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Guangzhou, 510655, China
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Hangzhou, 310003, China
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Hangzhou, 310014, China
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Hangzhou, 310020, China
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Harbin, 150081, China
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Hefei, 230031, China
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Hohhot, 010020, China
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Jinan, 2501117, China
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Kunming, 650118, China
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Lanzhou, 730000, China
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Linhai, 317000, China
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Linyi, 276000, China
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Nanchang, 330000, China
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Nanchang, 330029, China
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Nanjing, 2100008, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Nantong, 226361, China
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Shanghai, 200025, China
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Shanghai, 200127, China
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Shanghai, 20032, China
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Shantou, 515041, China
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Shenyang, 110016, China
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Shenzhen, 518036, China
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Tianjin, 300050, China
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Wuhan, 430030, China
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Wuhan, 430079, China
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Xi'an, 710068, China
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Xiamen, 361003, China
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Xingtai, 054031, China
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Xuzhou, 221009, China
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Yinchuan, 750004, China
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Zhengzhou, 450008, China
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Bordeaux, 33000, France
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Caen, 41076, France
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Lyon, 69373, France
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Marseille, 13273, France
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Rennes, 35000, France
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Villejuif, 94805, France
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Augsburg, 86156, Germany
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Bad Saarow, 15526, Germany
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Dresden, 01370, Germany
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Essen, 45122, Germany
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Essen, 45130, Germany
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Frankfurt, 60488, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20249, Germany
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Heidelberg, 69120, Germany
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Heilbronn, 74078, Germany
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Leipzig, 04103, Germany
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Lichtenberg, 10365, Germany
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Lübeck, 23538, Germany
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Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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Marburg, 35043, Germany
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Minden, 32429, Germany
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Moers, 47441, Germany
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München, 81657, Germany
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Stuttgart, 70376, Germany
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Ulm, 89081, Germany
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Budapest, 1083, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7624, Hungary
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Zalaegerszeg, 8900, Hungary
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Ahmedabad, 380060, India
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Bhubaneswar, 751019, India
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Hyderabad, 500032, India
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Kolkata, 700160, India
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Mohali, 140901, India
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Mohali, 160055, India
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Mumbai, 400012, India
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New Delhi, 110017, India
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New Delhi, 110060, India
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Varanasi, 221005, India
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Vijayawada, 520002, India
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Visakhapatnam, 530053, India
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Meldola, 47014, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Milan, 20162, Italy
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Padova, 35128, Italy
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Rozzano, 20089, Italy
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Tricase, 73039, Italy
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Bunkyō City, 113-8677, Japan
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Chūōku, 104-0045, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 730-8518, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kurashiki-shi, 710-8602, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Osaka, 543-8922, Japan
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Ota-shi, 373-8550, Japan
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Sagamihara-shi, 252-0375, Japan
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Sakai, 590-0197, Japan
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Sendai, 980-8574, Japan
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Shimotsuke-shi, 329-0498, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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George Town, 10450, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Petaling Jaya, 47500, Malaysia
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NOT_YET_RECRUITING

Amsterdam, 1081 HV, Netherlands
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Groningen, 9713 GZ, Netherlands
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NOT_YET_RECRUITING

Rotterdam, 3015 GD, Netherlands
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NOT_YET_RECRUITING

Tilburg, 5022 GC, Netherlands
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Gdansk, 80-219, Poland
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Koszalin, 75-581, Poland
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Krakow, 31-501, Poland
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Lublin, 20-080, Poland
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Olsztyn, 10-228, Poland
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Warsaw, 02-034, Poland
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San Juan, 00921, Puerto Rico
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Daegu, 41404, South Korea
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Hwasun-gun, 58128, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Barcelona, 08035, Spain
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Barcelona, 8036, Spain
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Madrid, 28041, Spain
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Pamplona, 31008, Spain
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Santander, 39008, Spain
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Santiago de Compostela, 15706, Spain
Research Site
RECRUITING

Valencia, 46010, Spain
Research Site
RECRUITING

Kaohsiung City, 80756, Taiwan
Research Site
RECRUITING

Kaohsiung City, 83301, Taiwan
Research Site
RECRUITING

Taichung, 40447, Taiwan
Research Site
RECRUITING

Taichung, 40705, Taiwan
Research Site
RECRUITING

Tainan, 704, Taiwan
Research Site
RECRUITING

Taipei, 10002, Taiwan
Research Site
RECRUITING

Taipei, 112, Taiwan
Research Site
RECRUITING

Taoyuan, 333, Taiwan
Research Site
RECRUITING

Bangkok, 10210, Thailand
Research Site
RECRUITING

Bangkok, 10700, Thailand
Research Site
RECRUITING

Dusit, 10300, Thailand
Research Site
RECRUITING

Hat Yai, 90110, Thailand
Research Site
RECRUITING

Khon Kaen, 40002, Thailand
Research Site
RECRUITING

Muang, 22000, Thailand
Research Site
RECRUITING

Muang, 70000, Thailand
Research Site
NOT_YET_RECRUITING

Ankara, 06530, Turkey (Türkiye)
Research Site
NOT_YET_RECRUITING

Antalya, 07100, Turkey (Türkiye)
Research Site
NOT_YET_RECRUITING

Istanbul, 34098, Turkey (Türkiye)
Research Site
NOT_YET_RECRUITING

Istanbul, 34854, Turkey (Türkiye)
Research Site
NOT_YET_RECRUITING

Medreseboğazı, 01250, Turkey (Türkiye)
Research Site
NOT_YET_RECRUITING

Şahinbey, 27310, Turkey (Türkiye)
Research Site
RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Research Site
RECRUITING

Dundee, DD1 9SY, United Kingdom
Research Site
RECRUITING

Leeds, LS9 7TF, United Kingdom
Research Site
RECRUITING

London, EC1A 7BE, United Kingdom
Research Site
RECRUITING

Manchester, M20 4BX, United Kingdom
Research Site
NOT_YET_RECRUITING

Oxford, OX3 7LE, United Kingdom
Research Site
NOT_YET_RECRUITING

Da Nang, 550000, Vietnam
Research Site
NOT_YET_RECRUITING

Hanoi, 100000, Vietnam
Research Site
NOT_YET_RECRUITING

Ho Chi Minh City, 700000, Vietnam
Research Site
NOT_YET_RECRUITING

Hồ Chí Minh, 700000, Vietnam
Research Site
NOT_YET_RECRUITING

Vinh, 460000, Vietnam

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