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 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)
2 other identifiers
interventional
2,130
21 countries
254
Brief 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 adenocarcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Feb 2026
Typical duration for phase_3 gastric-cancer
254 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2026
CompletedStudy Start
First participant enrolled
February 3, 2026
CompletedFirst Posted
Study publicly available on registry
February 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 27, 2031
April 13, 2026
April 1, 2026
3.5 years
January 16, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Up to approximately 5 years
Secondary Outcomes (12)
Overall Survival (OS) (Cohort 2)
Up to approximately 5 years
Overall Survival (OS) (Cohort 1)
Up to approximately 5 years
Progression Free Survival (PFS) (Cohort 1)
Up to approximately 5 years
Objective Response Rate (ORR) (Cohort 1 and Cohort 2)
Up to approximately 5 years
Duration of Response (DoR) (Cohort 1 and Cohort 2)
Up to approximately 5 years
- +7 more secondary outcomes
Study Arms (5)
Arm A
EXPERIMENTALSonesitatug vedotin + Rilvegostomig + Capecitabine
Arm B
EXPERIMENTALSonesitatug vedotin + Nivolumab + Capecitabine
Arm C
ACTIVE COMPARATORNivolumab + CAPOX OR Nivolumab + FOLFOX * nivolumab, capecitabine, oxaliplatin * nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin
Arm D
EXPERIMENTALSonesitatug vedotin + Capecitabine
Arm E
ACTIVE COMPARATORZolbetuximab + CAPOX or Zolbetuximab + FOLFOX: * zolbetuximab, capecitabine, oxaliplatin * zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin CAPOX or FOLFOX: * oxaliplatin, capecitabine, * 5-Fluorouracil, leucovorin, oxaliplatin
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (258)
Research Site
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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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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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, 40207, United States
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Boston, Massachusetts, 02114, United States
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Burlington, Massachusetts, 01803, 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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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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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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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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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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Sioux Falls, South Dakota, 57105, 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, 75246, 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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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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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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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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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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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Essen, 45122, 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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Mainz, 55131, Germany
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Mannheim, 68167, 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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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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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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Chūōku, 104-0045, Japan
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Hirakata-shi, 573-1191, 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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Ota-shi, 373-8550, Japan
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Sakai, 590-0197, Japan
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Sendai, 980-8574, 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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Groningen, 9713 GZ, Netherlands
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Rotterdam, 3015 GD, Netherlands
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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
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Valencia, 46010, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10700, Thailand
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Dusit, 10300, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 22000, Thailand
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Muang, 70000, Thailand
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Ankara, 06530, Turkey (Türkiye)
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Antalya, 07100, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34854, Turkey (Türkiye)
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Medreseboğazı, 01250, Turkey (Türkiye)
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Şahinbey, 27310, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, EC1A 7BE, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- This is an open-label study; however, it will be conducted 'sponsor blind' and the specific treatment to be taken by a participant will be assigned using an IRT/RTSM. To maintain the integrity of the study, sponsor access to treatment records will be restricted, unless a positive result is observed at an interim analysis and access is required as per protocol-defined procedures
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2026
First Posted
February 24, 2026
Study Start
February 3, 2026
Primary Completion (Estimated)
August 16, 2029
Study Completion (Estimated)
October 27, 2031
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via the secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing the requested information.
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.