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

May 25, 2026 updated by: AstraZeneca

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2130

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Australia
- - Darlinghurst, Australia, 2010
    - Suspended
    - Research Site
  - Garran, Australia, 2605
    - Withdrawn
    - Research Site
  - Heidelberg, Australia, 3084
    - Recruiting
    - Research Site
  - Murdoch, Australia, 6150
    - Recruiting
    - Research Site
  - Randwick, Australia, 2031
    - Recruiting
    - Research Site
  - Westmead, Australia, 2145
    - Recruiting
    - Research Site
Austria
- - Linz, Austria, 4010
    - Withdrawn
    - Research Site
  - Rankweil, Austria, 6830
    - Withdrawn
    - Research Site
  - Vienna, Austria, 1090
    - Withdrawn
    - Research Site
  - Wiener Neustadt, Austria, 2700
    - Withdrawn
    - Research Site
Belgium
- - Brussels, Belgium, 1200
    - Not yet recruiting
    - Research Site
  - Edegem, Belgium, 2650
    - Not yet recruiting
    - Research Site
  - Ghent, Belgium, 9000
    - Not yet recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Not yet recruiting
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Not yet recruiting
    - Research Site
  - Fortaleza, Brazil, 60336-045
    - Not yet recruiting
    - Research Site
  - Natal, Brazil, 59075-740
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350200
    - Not yet recruiting
    - Research Site
  - Salvador, Brazil, 41.950-610
    - Not yet recruiting
    - Research Site
  - Santa Maria, Brazil, 97015-450
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01246-000
    - Not yet recruiting
    - Research Site
  - Vitória, Brazil, 29043-260
    - Not yet recruiting
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Not yet recruiting
    - Research Site
- British Columbia
  - Abbotsford British Columbia, British Columbia, Canada, V2S0C2
    - Not yet recruiting
    - Research Site
  - Vancouver, British Columbia, Canada, VSZ 4E6
    - Not yet recruiting
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Withdrawn
    - Research Site
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 2Z3
    - Not yet recruiting
    - Research Site
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Not yet recruiting
    - Research Site
  - Brampton, Ontario, Canada, L6R 3J7
    - Recruiting
    - Research Site
  - Ottawa, Ontario, Canada, K1H 8L6
    - Not yet recruiting
    - Research Site
  - Sault Ste. Marie, Ontario, Canada, P6A 0A8
    - Not yet recruiting
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H3A 1A1
    - Recruiting
    - Research Site
  - Québec, Quebec, Canada, G1J 1Z4
    - Recruiting
    - Research Site
China
- - Beijing, China, 100050
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100142
    - Recruiting
    - Research Site
  - Beijing, China, 102200
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100032
    - Recruiting
    - Research Site
  - Changde, China, 415000
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610041
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 400016
    - Not yet recruiting
    - Research Site
  - Fuzhou, China, 350011
    - Not yet recruiting
    - Research Site
  - Fuzhou, China, 350005
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510655
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310020
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310003
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310014
    - Not yet recruiting
    - Research Site
  - Harbin, China, 150081
    - Not yet recruiting
    - Research Site
  - Hefei, China, 230031
    - Not yet recruiting
    - Research Site
  - Hohhot, China, 010020
    - Not yet recruiting
    - Research Site
  - Jinan, China, 2501117
    - Not yet recruiting
    - Research Site
  - Kunming, China, 650118
    - Not yet recruiting
    - Research Site
  - Lanzhou, China, 730000
    - Not yet recruiting
    - Research Site
  - Linhai, China, 317000
    - Not yet recruiting
    - Research Site
  - Linyi, China, 276000
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330000
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330029
    - Not yet recruiting
    - Research Site
  - Nanjing, China, 2100008
    - Not yet recruiting
    - Research Site
  - Nanjing, China, 210029
    - Not yet recruiting
    - Research Site
  - Nanning, China, 530021
    - Not yet recruiting
    - Research Site
  - Nantong, China, 226361
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200025
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200127
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 20032
    - Not yet recruiting
    - Research Site
  - Shantou, China, 515041
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110016
    - Not yet recruiting
    - Research Site
  - Shenzhen, China, 518036
    - Not yet recruiting
    - Research Site
  - Tianjin, China, 300050
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430030
    - Recruiting
    - Research Site
  - Wuhan, China, 430079
    - Not yet recruiting
    - Research Site
  - Xi'an, China, 710068
    - Not yet recruiting
    - Research Site
  - Xiamen, China, 361003
    - Not yet recruiting
    - Research Site
  - Xingtai, China, 054031
    - Not yet recruiting
    - Research Site
  - Xuzhou, China, 221009
    - Not yet recruiting
    - Research Site
  - Yinchuan, China, 750004
    - Not yet recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Not yet recruiting
    - Research Site
France
- - Bordeaux, France, 33000
    - Not yet recruiting
    - Research Site
  - Caen, France, 41076
    - Not yet recruiting
    - Research Site
  - Lyon, France, 69373
    - Not yet recruiting
    - Research Site
  - Marseille, France, 13273
    - Not yet recruiting
    - Research Site
  - Rennes, France, 35000
    - Not yet recruiting
    - Research Site
  - Villejuif, France, 94805
    - Not yet recruiting
    - Research Site
Germany
- - Augsburg, Germany, 86156
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 13353
    - Not yet recruiting
    - Research Site
  - Bonn, Germany, 53127
    - Not yet recruiting
    - Research Site
  - Essen, Germany, 45122
    - Not yet recruiting
    - Research Site
  - Frankfurt, Germany, 60488
    - Not yet recruiting
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 20249
    - Not yet recruiting
    - Research Site
  - Heidelberg, Germany, 69120
    - Withdrawn
    - Research Site
  - Heilbronn, Germany, 74078
    - Not yet recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Not yet recruiting
    - Research Site
  - Mainz, Germany, 55131
    - Not yet recruiting
    - Research Site
  - Mannheim, Germany, 68167
    - Withdrawn
    - Research Site
  - Moers, Germany, 47441
    - Not yet recruiting
    - Research Site
  - München, Germany, 81657
    - Not yet recruiting
    - Research Site
  - Stuttgart, Germany, 70376
    - Not yet recruiting
    - Research Site
  - Ulm, Germany, 89081
    - Not yet recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1083
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1122
    - Not yet recruiting
    - Research Site
  - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Not yet recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Not yet recruiting
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Not yet recruiting
    - Research Site
  - Pécs, Hungary, 7624
    - Not yet recruiting
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Not yet recruiting
    - Research Site
India
- - Ahmedabad, India, 380060
    - Not yet recruiting
    - Research Site
  - Bhubaneswar, India, 751019
    - Not yet recruiting
    - Research Site
  - Hyderabad, India, 500032
    - Not yet recruiting
    - Research Site
  - Mohali, India, 160055
    - Not yet recruiting
    - Research Site
  - Mohali, India, 140901
    - Not yet recruiting
    - Research Site
  - Mumbai, India, 400012
    - Not yet recruiting
    - Research Site
  - New Delhi, India, 110017
    - Not yet recruiting
    - Research Site
  - New Delhi, India, 110060
    - Withdrawn
    - Research Site
  - Varanasi, India, 221005
    - Withdrawn
    - Research Site
  - Vijayawada, India, 520002
    - Not yet recruiting
    - Research Site
  - Visakhapatnam, India, 530053
    - Not yet recruiting
    - Research Site
Italy
- - Meldola, Italy, 47014
    - Not yet recruiting
    - Research Site
  - Milan, Italy, 20141
    - Not yet recruiting
    - Research Site
  - Milan, Italy, 20133
    - Not yet recruiting
    - Research Site
  - Milan, Italy, 20162
    - Not yet recruiting
    - Research Site
  - Padova, Italy, 35128
    - Not yet recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Not yet recruiting
    - Research Site
  - Tricase, Italy, 73039
    - Not yet recruiting
    - Research Site
Japan
- - Chūōku, Japan, 104-0045
    - Recruiting
    - Research Site
  - Hirakata-shi, Japan, 573-1191
    - Not yet recruiting
    - Research Site
  - Kashiwa, Japan, 277-8577
    - Recruiting
    - Research Site
  - Kitaadachi-gun, Japan, 362-0806
    - Not yet recruiting
    - Research Site
  - Kurashiki-shi, Japan, 710-8602
    - Not yet recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Research Site
  - Niigata, Japan, 951-8566
    - Not yet recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Not yet recruiting
    - Research Site
  - Ota-shi, Japan, 373-8550
    - Not yet recruiting
    - Research Site
  - Sakai, Japan, 590-0197
    - Not yet recruiting
    - Research Site
  - Sendai, Japan, 980-8574
    - Not yet recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Not yet recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
  - Yokohama, Japan, 232-0024
    - Not yet recruiting
    - Research Site
Netherlands
- - Groningen, Netherlands, 9713 GZ
    - Not yet recruiting
    - Research Site
  - Rotterdam, Netherlands, 3015 GD
    - Not yet recruiting
    - Research Site
  - Tilburg, Netherlands, 5022 GC
    - Not yet recruiting
    - Research Site
Poland
- - Gdansk, Poland, 80-219
    - Not yet recruiting
    - Research Site
  - Koszalin, Poland, 75-581
    - Not yet recruiting
    - Research Site
  - Krakow, Poland, 31-501
    - Not yet recruiting
    - Research Site
  - Lublin, Poland, 20-080
    - Not yet recruiting
    - Research Site
  - Olsztyn, Poland, 10-228
    - Not yet recruiting
    - Research Site
  - Warsaw, Poland, 02-034
    - Not yet recruiting
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00921
    - Not yet recruiting
    - Research Site
South Korea
- - Daegu, South Korea, 41404
    - Not yet recruiting
    - Research Site
  - Hwasun-gun, South Korea, 58128
    - Not yet recruiting
    - Research Site
  - Seongnam-si, South Korea, 13620
    - Not yet recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 05505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Not yet recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Not yet recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08035
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 8036
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Research Site
  - Pamplona, Spain, 31008
    - Not yet recruiting
    - Research Site
  - Santander, Spain, 39008
    - Not yet recruiting
    - Research Site
  - Santiago de Compostela, Spain, 15706
    - Not yet recruiting
    - Research Site
  - Valencia, Spain, 46010
    - Not yet recruiting
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 83301
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 704
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 112
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10700
    - Not yet recruiting
    - Research Site
  - Bangkok, Thailand, 10210
    - Not yet recruiting
    - Research Site
  - Dusit, Thailand, 10300
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Not yet recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Not yet recruiting
    - Research Site
  - Muang, Thailand, 22000
    - Not yet recruiting
    - Research Site
  - Muang, Thailand, 70000
    - Not yet recruiting
    - Research Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06530
    - Not yet recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07100
    - Not yet recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34098
    - Not yet recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34854
    - Not yet recruiting
    - Research Site
  - Medreseboğazı, Turkey (Türkiye), 01250
    - Not yet recruiting
    - Research Site
  - Şahinbey, Turkey (Türkiye), 27310
    - Not yet recruiting
    - Research Site
United Kingdom
- - Cambridge, United Kingdom, CB2 0QQ
    - Not yet recruiting
    - Research Site
  - Dundee, United Kingdom, DD1 9SY
    - Not yet recruiting
    - Research Site
  - Leeds, United Kingdom, LS9 7TF
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, EC1A 7BE
    - Not yet recruiting
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Not yet recruiting
    - Research Site
  - Oxford, United Kingdom, OX3 7LE
    - Not yet recruiting
    - Research Site
United States
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Not yet recruiting
    - Research Site
- Arkansas
  - Springdale, Arkansas, United States, 72762
    - Not yet recruiting
    - Research Site
- California
  - Duarte, California, United States, 91010
    - Not yet recruiting
    - Research Site
  - Fullerton, California, United States, 92835
    - Not yet recruiting
    - Research Site
  - La Jolla, California, United States, 92093
    - Not yet recruiting
    - Research Site
  - Los Alamitos, California, United States, 90720
    - Not yet recruiting
    - Research Site
  - Orange, California, United States, 92868
    - Not yet recruiting
    - Research Site
  - Walnut Creek, California, United States, 94598
    - Not yet recruiting
    - Research Site
- Colorado
  - Denver, Colorado, United States, 80210
    - Not yet recruiting
    - Research Site
  - Lone Tree, Colorado, United States, 80124
    - Not yet recruiting
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Withdrawn
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Not yet recruiting
    - Research Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Withdrawn
    - Research Site
- Florida
  - Fort Myers, Florida, United States, 33901
    - Withdrawn
    - Research Site
  - Jacksonville, Florida, United States, 32224
    - Not yet recruiting
    - Research Site
  - Orlando, Florida, United States, 32806
    - Not yet recruiting
    - Research Site
  - St. Petersburg, Florida, United States, 33705
    - Withdrawn
    - Research Site
  - West Palm Beach, Florida, United States, 33401
    - Withdrawn
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Not yet recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30342
    - Withdrawn
    - Research Site
  - Atlanta, Georgia, United States, 30309
    - Not yet recruiting
    - Research Site
  - Macon, Georgia, United States, 31201
    - Not yet recruiting
    - Research Site
  - Newnan, Georgia, United States, 30265
    - Not yet recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Not yet recruiting
    - Research Site
  - Niles, Illinois, United States, 60714
    - Not yet recruiting
    - Research Site
  - Zion, Illinois, United States, 60099
    - Not yet recruiting
    - Research Site
- Indiana
  - Indianapolis, Indiana, United States, 46260
    - Not yet recruiting
    - Research Site
- Iowa
  - Waukee, Iowa, United States, 50263
    - Not yet recruiting
    - Research Site
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Not yet recruiting
    - Research Site
  - Louisville, Kentucky, United States, 40217
    - Not yet recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Not yet recruiting
    - Research Site
  - Burlington, Massachusetts, United States, 01803
    - Not yet recruiting
    - Research Site
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Research Site
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Not yet recruiting
    - Research Site
  - Duluth, Minnesota, United States, 55805
    - Not yet recruiting
    - Research Site
  - Rochester, Minnesota, United States, 55905
    - Not yet recruiting
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64132
    - Not yet recruiting
    - Research Site
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Research Site
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Not yet recruiting
    - Research Site
  - East Brunswick, New Jersey, United States, 08816
    - Recruiting
    - Research Site
  - Hackensack, New Jersey, United States, 07601
    - Not yet recruiting
    - Research Site
  - New Brunswick, New Jersey, United States, 08901
    - Not yet recruiting
    - Research Site
  - Summit, New Jersey, United States, 07901
    - Not yet recruiting
    - Research Site
- New York
  - New York, New York, United States, 10065
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10029
    - Withdrawn
    - Research Site
  - New York, New York, United States, 10032
    - Not yet recruiting
    - Research Site
  - The Bronx, New York, United States, 10461
    - Not yet recruiting
    - Research Site
  - The Bronx, New York, United States, 10468
    - Not yet recruiting
    - Research Site
  - White Plains, New York, United States, 10601
    - Withdrawn
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Not yet recruiting
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Not yet recruiting
    - Research Site
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Withdrawn
    - Research Site
  - Columbus, Ohio, United States, 43221
    - Not yet recruiting
    - Research Site
- Oregon
  - Portland, Oregon, United States, 97239
    - Not yet recruiting
    - Research Site
  - Portland, Oregon, United States, 97213
    - Not yet recruiting
    - Research Site
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Not yet recruiting
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Not yet recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15240
    - Not yet recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15232
    - Not yet recruiting
    - Research Site
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Not yet recruiting
    - Research Site
  - York, Pennsylvania, United States, 17403
    - Not yet recruiting
    - Research Site
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Not yet recruiting
    - Research Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Not yet recruiting
    - Research Site
- Tennessee
  - Memphis, Tennessee, United States, 38104
    - Withdrawn
    - Research Site
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Research Site
- Texas
  - Dallas, Texas, United States, 75246
    - Not yet recruiting
    - Research Site
  - Dallas, Texas, United States, 75235
    - Not yet recruiting
    - Research Site
  - Sherman, Texas, United States, 75090
    - Not yet recruiting
    - Research Site
- Virginia
  - Blacksburg, Virginia, United States, 24060
    - Not yet recruiting
    - Research Site
  - Fairfax, Virginia, United States, 22031
    - Not yet recruiting
    - Research Site
  - Falls Church, Virginia, United States, 22042
    - Withdrawn
    - Research Site
  - Fort Belvoir, Virginia, United States, 22060
    - Not yet recruiting
    - Research Site
  - Richmond, Virginia, United States, 23219
    - Not yet recruiting
    - Research Site
- Washington
  - Olympia, Washington, United States, 98502
    - Not yet recruiting
    - Research Site
  - Seattle, Washington, United States, 98104
    - Not yet recruiting
    - Research Site
- West Virginia
  - Charleston, West Virginia, United States, 25315
    - Not yet recruiting
    - Research Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Not yet recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A Sonesitatug vedotin + Rilvegostomig + Capecitabine	Drug: Capecitabine Oral Drug: Sonesitatug vedotin Intravenous Other Names: AZD0901 Drug: Rilvegostomig Intravenous Other Names: AZD2936
Experimental: Arm B Sonesitatug vedotin + Nivolumab + Capecitabine	Drug: Nivolumab Intravenous Drug: Capecitabine Oral Drug: Sonesitatug vedotin Intravenous Other Names: AZD0901
Active Comparator: Arm C Nivolumab + CAPOX OR Nivolumab + FOLFOX nivolumab, capecitabine, oxaliplatin nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin	Drug: Nivolumab Intravenous Drug: Leucovorin Intravenous Drug: Capecitabine Oral Drug: 5-Fluorouracil Intravenous Drug: Oxaliplatin Intravenous
Experimental: Arm D Sonesitatug vedotin + Capecitabine	Drug: Capecitabine Oral Drug: Sonesitatug vedotin Intravenous Other Names: AZD0901
Active Comparator: Arm E Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX: zolbetuximab, capecitabine, oxaliplatin zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin CAPOX or FOLFOX: oxaliplatin, capecitabine, 5-Fluorouracil, leucovorin, oxaliplatin	Drug: Leucovorin Intravenous Drug: Capecitabine Oral Drug: 5-Fluorouracil Intravenous Drug: Oxaliplatin Intravenous Drug: Zolbetuximab Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) (Cohort 1 and Cohort 2) Time Frame: Up to approximately 5 years	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) Time Frame: Up to approximately 5 years	OS is defined as the time from randomisation until the date of death due to any cause.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) (Cohort 2) Time Frame: Up to approximately 5 years	OS is defined as the time from randomisation until the date of death due to any cause.	Up to approximately 5 years
Overall Survival (OS) (Cohort 1) Time Frame: Up to approximately 5 years	OS is defined as time from randomisation until date of death due to any cause. Arm B versus C.	Up to approximately 5 years
Progression Free Survival (PFS) (Cohort 1) Time Frame: Up to approximately 5 years	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.	Up to approximately 5 years
Objective Response Rate (ORR) (Cohort 1 and Cohort 2) Time Frame: Up to approximately 5 years	ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, per RECIST 1.1.	Up to approximately 5 years
Duration of Response (DoR) (Cohort 1 and Cohort 2) Time Frame: Up to approximately 5 years	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).	Up to approximately 5 years
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2) Time Frame: Up to approximately 5 years	Pharmacokinetic parameters of sonesitatug vedotin (peak plasma concentration (Cmax))	Up to approximately 5 years
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2) Time Frame: Up to approximately 5 years	Pharmacokinetic parameters of sonesitatug vedotin (trough plasma concentration (Cmin))	Up to approximately 5 years
Immunogenicity of sonesitatug vedotin (Cohort 1 and Cohort 2) Time Frame: Up to approximately 5 years	Presence of ADAs for sonesitatug vedotin in serum (confirmatory results: positive or negative, titres).	Up to approximately 5 years
Pharmacokinetics of rilvegostomig (Cohort 1) Time Frame: Up to approximately 5 years	Pharmacokinetic parameters of rilvegostomig (peak plasma concentration (Cmax))	Up to approximately 5 years
Pharmacokinetics of rilvegostomig (Cohort 1) Time Frame: Up to approximately 5 years	Pharmacokinetic parameters of rilvegostomig (trough plasma concentration (Cmin))	Up to approximately 5 years
Immunogenicity of rilvegostomig (Cohort 1) Time Frame: Up to approximately 5 years	Presence of ADAs for rilvegostomig in serum (confirmatory results: positive or negative, titres).	Up to approximately 5 years
Safety and tolerability (Cohort 1 and Cohort 2) Time Frame: Up to approximately 5 years	Safety and tolerability as evaluated in terms of incidence of AEs and SAEs	Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2026

Primary Completion (Estimated)

August 16, 2029

Study Completion (Estimated)

October 27, 2031

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D9803C00001
2024-519787-40-00 (Registry Identifier: Clinical Trials Information System (CTIS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

City of Hope Medical Center

Completed

Stomach Cancer Exosome-based Detection (DESTINEX)

Gastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditions

United States, Japan
City of Hope Medical Center
National Cancer Institute (NCI)

Active, not recruiting

Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

Gastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditions

United States
City of Hope Medical Center

Completed

64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer

Adenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditions

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

Gastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditions

United States
National Cancer Institute (NCI)

Completed

Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction

Gastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric Cancer

United States
Ukrainian Society of Clinical Oncology

Recruiting

Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer (ICGastr)

Gastric Cancer | Gastrectomy for Gastric Cancer | Gastric Cancer Stage III | Gastric Cancer Stage II

Ukraine
Lin Liu

Recruiting

The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer

Gastric Carcinoma | Gastric Neoplasm | Gastric Cancer Adenocarcinoma Metastatic | Gastric (cardia, Body) Cancer

China
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)

Active, not recruiting

Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer

Gastric Adenocarcinoma | Epstein-Barr Virus Positive | Mismatch Repair Protein Deficiency | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage III Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage... and other conditions

United States
Mayo Clinic
National Cancer Institute (NCI)

Completed

Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery

Gastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7

United States
Shanghai Changzheng Hospital

Not yet recruiting

HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer

Gastric Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Locally Advanced Gastric Cancer

Clinical Trials on Nivolumab

Universitair Ziekenhuis Brussel

Recruiting

A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma (NEO-GLITIPNI)

Recurrent Glioblastoma

Belgium
Brown University
Bristol-Myers Squibb; The Miriam Hospital; Rhode Island Hospital; Women and Infants...

Terminated

BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer

Cervical Cancer

United States
Baptist Health South Florida
Bristol-Myers Squibb; NovoCure Ltd.

Terminated

Trial of Combination TTF(Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma

Recurrent Glioblastoma

United States
Michael B. Atkins, MD
Bristol-Myers Squibb; Hoosier Cancer Research Network

Completed

Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma

Advanced Renal Cell Carcinoma

United States
Bristol-Myers Squibb

Active, not recruiting

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

Melanoma

Spain, Greece, Italy, United States, Chile
Jennifer Zhang
Alligator Bioscience AB

Recruiting

Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC) (WINIT-BC)

Breast Cancer

United States
Bristol-Myers Squibb

Completed

An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

Lung Cancer

Italy, United States, France, Russian Federation, Spain, Argentina, Belgium, Brazil, Canada, Chile, Czechia, Germany, Greece, Hungary, Mexico, Netherlands, Poland, Romania, Switzerland, Turkey, United Kingdom
IRCCS San Raffaele
Bristol-Myers Squibb

Recruiting

An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo) (NURE-Combo)

Muscle-Invasive Bladder Carcinoma

Italy
Guliz Ozgun
British Columbia Cancer Agency

Not yet recruiting

The Impact of Time-of-day-Dependent Administration of Nivolumab-Ipilimumab (ICI/ICI) Combination on Overall Survival in Adults With Advanced Kidney Cancer: A Pragmatic Multicenter, Randomized Controlled Trial.

Advanced Kidney Cancer

Canada
National Health Research Institutes, Taiwan
National Taiwan University Hospital; Mackay Memorial Hospital; China Medical... and other collaborators

Completed

Nivolumab Plus Ipilimumab as Neoadjuvant Therapy for Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma (HCC)

Taiwan

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)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Gastric Cancer

Clinical Trials on Nivolumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations