Gastric CancerPhase 3NCT07431281
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
A Phase 3 study testing Sonesitatug vedotin, Rilvegostomig and Nivolumab in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by AstraZeneca at 314 sites in 24 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer
- What is being tested?
- Sonesitatug vedotin, Rilvegostomig and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,130 participants
- Where
- 314 sitesin 24 countries
- Study dates
- 3 Feb 2026to 27 Oct 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
314 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
314 sites in 24 countries
United States93 sites, 81 recruiting
- Not yet recruiting
Research Site
Anchorage, Alaska, 99508
- Recruiting
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Atlanta, Georgia, 30309
- Recruiting
Research Site
Atlanta, Georgia, 30322
- Withdrawn
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Atlanta, Georgia, 30342
- Not yet recruiting
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Birmingham, Alabama, 35294-3300
- Recruiting
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Blacksburg, Virginia, 24060
- Not yet recruiting
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Boston, Massachusetts, 02114
- Not yet recruiting
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Burlington, Massachusetts, 01803
- Recruiting
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Burnsville, Minnesota, 55337
- Not yet recruiting
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Camden, New Jersey, 08103
- Not yet recruiting
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Charleston, South Carolina, 29425
- Not yet recruiting
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Charleston, West Virginia, 25304
- Recruiting
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Charlotte, North Carolina, 28204
- Not yet recruiting
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Chicago, Illinois, 60637
- Withdrawn
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Cleveland, Ohio, 44195
- Not yet recruiting
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Columbus, Ohio, 43221
- Not yet recruiting
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Dallas, Texas, 75235
- Recruiting
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Dallas, Texas, 75246
- Not yet recruiting
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Denver, Colorado, 80210
- Not yet recruiting
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Duarte, California, 91010
- Not yet recruiting
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Duluth, Minnesota, 55805
- Recruiting
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East Brunswick, New Jersey, 08816
- Recruiting
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Edmonds, Washington, 98026
- Recruiting
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Fairfax, Virginia, 22031
- Withdrawn
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Falls Church, Virginia, 22042
- Not yet recruiting
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Fort Belvoir, Virginia, 22060
- Withdrawn
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Fort Myers, Florida, 33901
- Recruiting
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Fountain Valley, California, 92708
- Not yet recruiting
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Fullerton, California, 92835
- Recruiting
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Grand Rapids, Michigan, 49503
- Not yet recruiting
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Hackensack, New Jersey, 07601
- Not yet recruiting
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Hershey, Pennsylvania, 17033
- Not yet recruiting
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Houston, Texas, 77030
- Recruiting
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Indianapolis, Indiana, 46260
- Recruiting
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Irvine, California, 92612
- Recruiting
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Issaquah, Washington, 98029
- Not yet recruiting
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Jacksonville, Florida, 32207
- Recruiting
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Jacksonville, Florida, 32224
- Recruiting
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Kansas City, Missouri, 64132
- Recruiting
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La Jolla, California, 92093
- Not yet recruiting
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Lexington, Kentucky, 40536
- Recruiting
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Lone Tree, Colorado, 80124
- Not yet recruiting
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Los Alamitos, California, 90720
- Not yet recruiting
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Louisville, Kentucky, 40217
- Recruiting
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Macon, Georgia, 31201
- Withdrawn
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Memphis, Tennessee, 38104
- Not yet recruiting
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Milwaukee, Wisconsin, 53226
- Not yet recruiting
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Minneapolis, Minnesota, 55455
- Not yet recruiting
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Mobile, Alabama, 36604
- Recruiting
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Nashville, Tennessee, 37203
- Not yet recruiting
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New Brunswick, New Jersey, 08901
- Withdrawn
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New Haven, Connecticut, 06510
- Withdrawn
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New York, New York, 10029
- Not yet recruiting
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New York, New York, 10032
- Recruiting
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New York, New York, 10065
- Not yet recruiting
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Newark, Delaware, 19713
- Not yet recruiting
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Newnan, Georgia, 30265
- Recruiting
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Niles, Illinois, 60714
- Not yet recruiting
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Olympia, Washington, 98502
- Recruiting
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Orange, California, 92868
- Not yet recruiting
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Orlando, Florida, 32806
- Recruiting
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Philadelphia, Pennsylvania, 19104
- Recruiting
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Phoenix, Arizona, 85054
- Recruiting
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Pittsburgh, Pennsylvania, 15232
- Not yet recruiting
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Pittsburgh, Pennsylvania, 15240
- Recruiting
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Portland, Oregon, 97213
- Not yet recruiting
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Portland, Oregon, 97239
- Not yet recruiting
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Providence, Rhode Island, 02903
- Recruiting
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Richmond, Virginia, 23219
- Recruiting
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Rochester, Minnesota, 55905
- Recruiting
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Seattle, Washington, 98104
- Recruiting
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Sherman, Texas, 75090
- Not yet recruiting
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Silver Spring, Maryland, 20910
- Recruiting
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Sioux Falls, South Dakota, 57105
- Not yet recruiting
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Springdale, Arkansas, 72762
- Recruiting
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St Louis, Missouri, 63110
- Withdrawn
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St. Petersburg, Florida, 33705
- Recruiting
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Summit, New Jersey, 07901
- Not yet recruiting
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The Bronx, New York, 10461
- Recruiting
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The Bronx, New York, 10468
- Recruiting
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Walnut Creek, California, 94598
- Withdrawn
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Washington D.C., District of Columbia, 20007
- Not yet recruiting
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Waukee, Iowa, 50263
- Withdrawn
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West Palm Beach, Florida, 33401
- Withdrawn
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White Plains, New York, 10601
- Not yet recruiting
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Whittier, California, 90602
- Recruiting
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Wilkes-Barre, Pennsylvania, 18711
- Recruiting
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Wilmington, North Carolina, 28403
- Recruiting
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Winston-Salem, North Carolina, 27103
- Withdrawn
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Worcester, Massachusetts, 01655
- Recruiting
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Yankton, South Dakota, 57078
- Recruiting
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York, Pennsylvania, 17403
- Not yet recruiting
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Zion, Illinois, 60099
China43 sites, 43 recruiting
- Recruiting
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Beijing, 100032
- Not yet recruiting
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Beijing, 100050
- Recruiting
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Beijing, 100142
- Not yet recruiting
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Beijing, 102200
- Not yet recruiting
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Changde, 415000
- Recruiting
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Chengdu, 610041
- Not yet recruiting
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Chengdu, 610041
- Not yet recruiting
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Chongqing, 400016
- Not yet recruiting
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Fuzhou, 350005
- Not yet recruiting
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Fuzhou, 350011
- Recruiting
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Guangzhou, 510655
- Not yet recruiting
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Hangzhou, 310003
- Not yet recruiting
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Hangzhou, 310014
- Not yet recruiting
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Hangzhou, 310020
- Recruiting
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Harbin, 150081
- Not yet recruiting
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Hefei, 230031
- Not yet recruiting
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Hohhot, 010020
- Recruiting
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Jinan, 2501117
- Not yet recruiting
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Kunming, 650118
- Recruiting
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Lanzhou, 730000
- Not yet recruiting
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Linhai, 317000
- Not yet recruiting
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Linyi, 276000
- Not yet recruiting
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Nanchang, 330000
- Not yet recruiting
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Nanchang, 330029
- Not yet recruiting
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Nanjing, 2100008
- Not yet recruiting
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Nanjing, 210029
- Not yet recruiting
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Nanning, 530021
- Not yet recruiting
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Nantong, 226361
- Not yet recruiting
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Shanghai, 200025
- Recruiting
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Shanghai, 200127
- Not yet recruiting
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Shanghai, 20032
- Not yet recruiting
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Shantou, 515041
- Not yet recruiting
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Shenyang, 110016
- Not yet recruiting
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Shenzhen, 518036
- Not yet recruiting
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Tianjin, 300050
- Recruiting
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Wuhan, 430030
- Not yet recruiting
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Wuhan, 430079
- Not yet recruiting
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Xi'an, 710068
- Not yet recruiting
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Xiamen, 361003
- Not yet recruiting
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Xingtai, 054031
- Not yet recruiting
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Xuzhou, 221009
- Not yet recruiting
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Yinchuan, 750004
- Not yet recruiting
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Zhengzhou, 450008
Germany24 sites, 22 recruiting
- Not yet recruiting
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Augsburg, 86156
- Not yet recruiting
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Bad Saarow, 15526
- Not yet recruiting
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Berlin, 13353
- Not yet recruiting
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Bonn, 53127
- Not yet recruiting
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Dresden, 01370
- Not yet recruiting
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Essen, 45122
- Not yet recruiting
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Essen, 45130
- Recruiting
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Frankfurt, 60488
- Recruiting
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Freiburg im Breisgau, 79106
- Not yet recruiting
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Hamburg, 20249
- Withdrawn
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Heidelberg, 69120
- Recruiting
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Heilbronn, 74078
- Recruiting
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Leipzig, 04103
- Not yet recruiting
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Lichtenberg, 10365
- Not yet recruiting
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Lübeck, 23538
- Not yet recruiting
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Magdeburg, 39120
- Not yet recruiting
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Mainz, 55131
- Withdrawn
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Mannheim, 68167
- Not yet recruiting
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Marburg, 35043
- Not yet recruiting
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Minden, 32429
- Recruiting
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Moers, 47441
- Recruiting
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München, 81657
- Recruiting
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Stuttgart, 70376
- Recruiting
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Ulm, 89081
Japan20 sites, 20 recruiting
- Not yet recruiting
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Bunkyō City, 113-8677
- Recruiting
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Chūōku, 104-0045
- Recruiting
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Hirakata-shi, 573-1191
- Recruiting
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Hiroshima, 730-8518
- Recruiting
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Kashiwa, 277-8577
- Recruiting
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Kitaadachi-gun, 362-0806
- Recruiting
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Kōtoku, 135-8550
- Recruiting
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Kurashiki-shi, 710-8602
- Recruiting
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Nagoya, 464-8681
- Recruiting
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Niigata, 951-8566
- Recruiting
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Osaka, 541-8567
- Not yet recruiting
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Osaka, 543-8922
- Recruiting
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Ota-shi, 373-8550
- Recruiting
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Sagamihara-shi, 252-0375
- Recruiting
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Sakai, 590-0197
- Not yet recruiting
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Sendai, 980-8574
- Not yet recruiting
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Shimotsuke-shi, 329-0498
- Recruiting
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Sunto-gun, 411-8777
- Recruiting
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Yokohama, 232-0024
- Recruiting
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Yokohama, 241-8515
Canada13 sites, 12 recruiting
- Recruiting
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Abbotsford British Columbia, British Columbia, V2S0C2
- Recruiting
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Barrie, Ontario, L4M 6M2
- Recruiting
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Brampton, Ontario, L6R 3J7
- Not yet recruiting
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Edmonton, Alberta, T6G 1Z2
- Recruiting
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Moncton, New Brunswick, E1C 2Z3
- Recruiting
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Montreal, Quebec, H3A 1A1
- Recruiting
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Ottawa, Ontario, K1H 8L6
- Recruiting
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Québec, Quebec, G1J 1Z4
- Recruiting
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Sault Ste. Marie, Ontario, P6A 0A8
- Recruiting
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Toronto, Ontario, M4N 3M5
- Recruiting
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Toronto, Ontario, M5G 2M9
- Not yet recruiting
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Vancouver, British Columbia, VSZ 4E6
- Withdrawn
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Winnipeg, Manitoba, R3E 0V9
India12 sites, 9 recruiting
- Recruiting
Research Site
Ahmedabad, 380060
- Withdrawn
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Bhubaneswar, 751019
- Recruiting
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Hyderabad, 500032
- Not yet recruiting
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Kolkata, 700160
- Not yet recruiting
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Mohali, 140901
- Not yet recruiting
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Mohali, 160055
- Recruiting
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Mumbai, 400012
- Recruiting
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New Delhi, 110017
- Withdrawn
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New Delhi, 110060
- Withdrawn
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Varanasi, 221005
- Not yet recruiting
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Vijayawada, 520002
- Not yet recruiting
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Visakhapatnam, 530053
Brazil8 sites, 8 recruiting
- Recruiting
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Barretos, 14784-400
- Recruiting
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Fortaleza, 60336-045
- Recruiting
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Natal, 59075-740
- Recruiting
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Porto Alegre, 91350200
- Recruiting
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Salvador, 41.950-610
- Recruiting
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Santa Maria, 97015-450
- Recruiting
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São Paulo, 01246-000
- Recruiting
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Vitória, 29043-260
Hungary8 sites, 7 recruiting
- Recruiting
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Budapest, 1083
- Recruiting
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Budapest, 1122
- Recruiting
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Debrecen, 4032
- Recruiting
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Győr, 9024
- Withdrawn
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Gyula, 5700
- Recruiting
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Nyíregyháza, 4400
- Recruiting
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Pécs, 7624
- Not yet recruiting
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Zalaegerszeg, 8900
South Korea8 sites, 8 recruiting
- Recruiting
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Daegu, 41404
- Recruiting
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Hwasun-gun, 58128
- Recruiting
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Seongnam-si, 13620
- Recruiting
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Seoul, 03080
- Recruiting
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Seoul, 03722
- Recruiting
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Seoul, 05505
- Recruiting
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Seoul, 06351
- Not yet recruiting
Research Site
Seoul, 06591
Taiwan8 sites, 8 recruiting
- Recruiting
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Kaohsiung City, 80756
- Recruiting
Research Site
Kaohsiung City, 83301
- Recruiting
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Taichung, 40447
- Recruiting
Research Site
Taichung, 40705
- Recruiting
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Tainan, 704
- Recruiting
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Taipei, 10002
- Recruiting
Research Site
Taipei, 112
- Recruiting
Research Site
Taoyuan, 333
Australia7 sites, 5 recruiting
- Withdrawn
Research Site
Darlinghurst, 2010
- Withdrawn
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Garran, 2605
- Recruiting
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Heidelberg, 3084
- Recruiting
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Murdoch, 6150
- Recruiting
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Randwick, 2031
- Recruiting
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Westmead, 2145
- Not yet recruiting
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Woolloongabba, 4102
Italy7 sites, 7 recruiting
- Recruiting
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Meldola, 47014
- Not yet recruiting
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Milan, 20133
- Recruiting
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Milan, 20141
- Recruiting
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Milan, 20162
- Recruiting
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Padova, 35128
- Recruiting
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Rozzano, 20089
- Recruiting
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Tricase, 73039
Malaysia7 sites, 7 recruiting
- Not yet recruiting
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George Town, 10450
- Not yet recruiting
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Kota Bharu, 15586
- Not yet recruiting
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Kota Kinabalu, 88996
- Not yet recruiting
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Kuala Lumpur, 59100
- Not yet recruiting
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Kuching, 93586
- Not yet recruiting
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Petaling Jaya, 46300
- Not yet recruiting
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Petaling Jaya, 47500
Spain7 sites, 7 recruiting
- Recruiting
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Barcelona, 08035
- Recruiting
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Barcelona, 8036
- Recruiting
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Madrid, 28041
- Recruiting
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Pamplona, 31008
- Recruiting
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Santander, 39008
- Recruiting
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Santiago de Compostela, 15706
- Recruiting
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Valencia, 46010
Thailand7 sites, 7 recruiting
- Recruiting
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Bangkok, 10210
- Recruiting
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Bangkok, 10700
- Recruiting
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Dusit, 10300
- Recruiting
Research Site
Hat Yai, 90110
- Recruiting
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Khon Kaen, 40002
- Recruiting
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Muang, 22000
- Recruiting
Research Site
Muang, 70000
France6 sites, 5 recruiting
- Recruiting
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Bordeaux, 33000
- Recruiting
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Caen, 41076
- Recruiting
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Lyon, 69373
- Withdrawn
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Marseille, 13273
- Recruiting
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Rennes, 35000
- Not yet recruiting
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Villejuif, 94805
Poland6 sites, 6 recruiting
- Recruiting
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Gdansk, 80-219
- Recruiting
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Koszalin, 75-581
- Recruiting
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Krakow, 31-501
- Recruiting
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Lublin, 20-080
- Recruiting
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Olsztyn, 10-228
- Recruiting
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Warsaw, 02-034
Turkey (Türkiye)6 sites, 6 recruiting
- Not yet recruiting
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Ankara, 06530
- Not yet recruiting
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Antalya, 07100
- Not yet recruiting
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Istanbul, 34098
- Not yet recruiting
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Istanbul, 34854
- Not yet recruiting
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Medreseboğazı, 01250
- Not yet recruiting
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Şahinbey, 27310
United Kingdom6 sites, 6 recruiting
- Recruiting
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Cambridge, CB2 0QQ
- Recruiting
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Dundee, DD1 9SY
- Recruiting
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Leeds, LS9 7TF
- Recruiting
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London, EC1A 7BE
- Recruiting
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Manchester, M20 4BX
- Recruiting
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Oxford, OX3 7LE
Vietnam5 sites, 5 recruiting
- Not yet recruiting
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Da Nang, 550000
- Not yet recruiting
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Hanoi, 100000
- Not yet recruiting
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Hồ Chí Minh, 700000
- Not yet recruiting
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Ho Chi Minh City, 700000
- Not yet recruiting
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Vinh, 460000
Austria4 sites
- Withdrawn
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Linz, 4010
- Withdrawn
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Rankweil, 6830
- Withdrawn
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Vienna, 1090
- Withdrawn
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Wiener Neustadt, 2700
Belgium4 sites, 4 recruiting
- Not yet recruiting
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Brussels, 1200
- Not yet recruiting
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Edegem, 2650
- Not yet recruiting
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Ghent, 9000
- Not yet recruiting
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Leuven, 3000
Netherlands4 sites, 4 recruiting
- Not yet recruiting
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Amsterdam, 1081 HV
- Not yet recruiting
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Groningen, 9713 GZ
- Not yet recruiting
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Rotterdam, 3015 GD
- Not yet recruiting
Research Site
Tilburg, 5022 GC
About this study
Official title: A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
Read the detailed description
The purpose of this Phase III study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in 1L CLDN18.2-positive, HER2-negative gastric, GEJ, and esophageal adenocarcinoma, and the clinical performance of the investigation in vitro diagnostics (IVDs). The study will include 2 cohorts to provide a treatment option for all participants that are HER2-negative and CLDN18.2-positive. Cohort 1 will evaluate sonesitatug vedotin in combination with rilvegostomig with capecitabine in participants who are CLDN18.2-positive and programmed death-ligand 1 (PD-L1) positive. Cohort 2 will evaluate sonesitatug vedotin in combination with capecitabine in participants who are CLDN18.2-positive and PD-L1 negative or immune checkpoint inhibitor (ICI) ineligible.
- Being tested
- Sonesitatug vedotin, Rilvegostomig, Nivolumab, Capecitabine, 5-Fluorouracil
- Keywords
- Advanced Gastroesophageal Junction (GEJ) Adenocarcinoma,, Advanced Gastric Adenocarcinoma,, Advanced Esophageal Adenocarcinoma,, Metastatic Gastric Adenocarcinoma,, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma,, Metastatic Esophageal Adenocarcinoma,, Claudin 18.2,, PD-L1,, Human epidermal growth factor receptor 2 (HER2) Negative
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Adenocarcinoma, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonesitatug vedotinDrug
Also called AZD0901
Intravenous
RilvegostomigDrug
Also called AZD2936
Intravenous
NivolumabDrug
Intravenous
CapecitabineDrug
Oral
5-FluorouracilDrug
Intravenous
OxaliplatinDrug
Intravenous
ZolbetuximabDrug
Intravenous
LeucovorinDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Sonesitatug vedotin + Rilvegostomig + Capecitabine Receives: Drug: Sonesitatug vedotin; Drug: Rilvegostomig; Drug: Capecitabine |
| Arm B | Experimental | Sonesitatug vedotin + Nivolumab + Capecitabine Receives: Drug: Sonesitatug vedotin; Drug: Nivolumab; Drug: Capecitabine |
| Arm C | Active comparator | Nivolumab + CAPOX OR Nivolumab + FOLFOX
* nivolumab, capecitabine, oxaliplatin
* nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin Receives: Drug: Nivolumab; Drug: Capecitabine; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin |
| Arm D | Experimental | Sonesitatug vedotin + Capecitabine Receives: Drug: Sonesitatug vedotin; Drug: Capecitabine |
| Arm E | Active comparator | Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX:
* zolbetuximab, capecitabine, oxaliplatin
* zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin
CAPOX or FOLFOX:
* oxaliplatin, capecitabine,
* 5-Fluorouracil, leucovorin, oxaliplatin Receives: Drug: Capecitabine; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: Zolbetuximab; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) (Cohort 1 and Cohort 2)
PFS is defined as time from randomisation until progression per RECIST 1.1, or death due to any cause, whichever occurs first.
Measured: Up to approximately 5 years
Overall Survival (OS) (Cohort 1)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Up to approximately 5 years
Secondary outcomes (12)
Overall Survival (OS) (Cohort 2)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Up to approximately 5 years
Overall Survival (OS) (Cohort 1)
OS is defined as time from randomisation until date of death due to any cause. Arm B versus C.
Measured: Up to approximately 5 years
Progression Free Survival (PFS) (Cohort 1)
PFS is defined as time from randomisation until progression per RECIST 1.1 or death due to any cause, whichever occurs first. Arms B versus C.
Measured: Up to approximately 5 years
Objective Response Rate (ORR) (Cohort 1 and Cohort 2)
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, per RECIST 1.1.
Measured: Up to approximately 5 years
Duration of Response (DoR) (Cohort 1 and Cohort 2)
DoR (per RECIST 1.1) is derived for confirmed objective responses (CR or PR) only and is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of disease progression (ie, date of PFS event - date of first response + 1).
Measured: Up to approximately 5 years
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2)
Pharmacokinetic parameters of sonesitatug vedotin (peak plasma concentration (Cmax))
Measured: Up to approximately 5 years
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2)
Pharmacokinetic parameters of sonesitatug vedotin (trough plasma concentration (Cmin))
Measured: Up to approximately 5 years
Immunogenicity of sonesitatug vedotin (Cohort 1 and Cohort 2)
Presence of ADAs for sonesitatug vedotin in serum (confirmatory results: positive or negative, titres).
Measured: Up to approximately 5 years
Pharmacokinetics of rilvegostomig (Cohort 1)
Pharmacokinetic parameters of rilvegostomig (peak plasma concentration (Cmax))
Measured: Up to approximately 5 years
Pharmacokinetics of rilvegostomig (Cohort 1)
Pharmacokinetic parameters of rilvegostomig (trough plasma concentration (Cmin))
Measured: Up to approximately 5 years
Immunogenicity of rilvegostomig (Cohort 1)
Presence of ADAs for rilvegostomig in serum (confirmatory results: positive or negative, titres).
Measured: Up to approximately 5 years
Safety and tolerability (Cohort 1 and Cohort 2)
Safety and tolerability as evaluated in terms of incidence of AEs and SAEs
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start3 Feb 2026
- Primary completion16 Aug 2029 (estimated)
- Study completion27 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1 (3-arm design) will evaluate sonesitatug vedotin in combination with rilvegostomig and capecitabine (Arm A) or sonesitatug vedotin in combination with nivolumab and capecitabine (Arm B), versus SoC nivolumab plus capecitabine plus oxaliplatin (CAPOX) or folinic acid, 5-fluorouracil, and oxaliplatin (FOLFOX) (Arm C) in PD-L1 positive participants. Participants will be randomized 1:1:1 to Arms A, B, or C. Cohort 2 (2-arm design) will evaluate sonesitatug vedotin in combination with capecitabine (Arm D) versus SoC (Arm E) in participants who are PD-L1 negative or ICI-ineligible. Participants will be randomised 1:1. SoC is CAPOX or FOLFOX alone or in combination with zolbetuximab.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431281
- Sponsor's protocol ID
- D9803C00001
- Other IDs
- 2024-519787-40-00
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. 'Yes' indicates that AstraZeneca is accepting requests for IPD, but this does not mean that all requests will be shared.