RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07431281

Registry updated: 2026-10-16

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Description

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.

Interventions

Sonesitatug vedotin (Drug)
Intravenous
Rilvegostomig (Drug)
Intravenous
Nivolumab (Drug)
Intravenous
Capecitabine (Drug)
Oral
5-Fluorouracil (Drug)
Intravenous
Oxaliplatin (Drug)
Intravenous
Zolbetuximab (Drug)
Intravenous
Leucovorin (Drug)
Intravenous

Eligibility criteria

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

Conditions

Gastric Cancer Gastroesophageal Junction Adenocarcinoma Esophageal Cancer

Locations

Research Site — Birmingham, Alabama, United States
Research Site — Mobile, Alabama, United States
Research Site — Anchorage, Alaska, United States
Research Site — Phoenix, Arizona, United States
Research Site — Springdale, Arkansas, United States
Research Site — Duarte, California, United States
Research Site — Fountain Valley, California, United States
Research Site — Fullerton, California, United States
Research Site — Irvine, California, United States
Research Site — La Jolla, California, United States
Research Site — Los Alamitos, California, United States
Research Site — Orange, California, United States
Research Site — Walnut Creek, California, United States
Research Site — Whittier, California, United States
Research Site — Denver, Colorado, United States
Research Site — Lone Tree, Colorado, United States
Research Site — New Haven, Connecticut, United States
Research Site — Newark, Delaware, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Fort Myers, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — St. Petersburg, Florida, United States
Research Site — West Palm Beach, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Macon, Georgia, United States
Research Site — Newnan, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Niles, Illinois, United States
Research Site — Zion, Illinois, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Waukee, Iowa, United States
Research Site — Lexington, Kentucky, United States
Research Site — Louisville, Kentucky, United States
Research Site — Silver Spring, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Burlington, Massachusetts, United States
Research Site — Worcester, Massachusetts, United States
Research Site — Grand Rapids, Michigan, United States
Research Site — Burnsville, Minnesota, United States
Research Site — Duluth, Minnesota, United States
Research Site — Minneapolis, Minnesota, United States
Research Site — Rochester, Minnesota, United States
Research Site — Kansas City, Missouri, United States
Research Site — St Louis, Missouri, United States
Research Site — Camden, New Jersey, United States
Research Site — East Brunswick, New Jersey, United States
Research Site — Hackensack, New Jersey, United States
Research Site — New Brunswick, New Jersey, United States
Research Site — Summit, New Jersey, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — The Bronx, New York, United States
Research Site — The Bronx, New York, United States
Research Site — White Plains, New York, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Wilmington, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Cleveland, Ohio, United States
Research Site — Columbus, Ohio, United States
Research Site — Portland, Oregon, United States
Research Site — Portland, Oregon, United States
Research Site — Hershey, Pennsylvania, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Wilkes-Barre, Pennsylvania, United States
Research Site — York, Pennsylvania, United States
Research Site — Providence, Rhode Island, United States
Research Site — Charleston, South Carolina, United States
Research Site — Sioux Falls, South Dakota, United States
Research Site — Yankton, South Dakota, United States
Research Site — Memphis, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Dallas, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Sherman, Texas, United States
Research Site — Blacksburg, Virginia, United States
Research Site — Fairfax, Virginia, United States
Research Site — Falls Church, Virginia, United States
Research Site — Fort Belvoir, Virginia, United States
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Research Site — Edmonds, Washington, United States
Research Site — Issaquah, Washington, United States
Research Site — Olympia, Washington, United States
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Research Site — Charleston, West Virginia, United States
Research Site — Milwaukee, Wisconsin, United States
Research Site — Darlinghurst, Australia
Research Site — Garran, Australia
Research Site — Heidelberg, Australia
Research Site — Murdoch, Australia
Research Site — Randwick, Australia
Research Site — Westmead, Australia
Research Site — Woolloongabba, Australia
Research Site — Linz, Austria
Research Site — Rankweil, Austria
Research Site — Vienna, Austria
Research Site — Wiener Neustadt, Austria
Research Site — Brussels, Belgium
Research Site — Edegem, Belgium
Research Site — Ghent, Belgium
Research Site — Leuven, Belgium
Research Site — Barretos, Brazil
Research Site — Fortaleza, Brazil
Research Site — Natal, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Salvador, Brazil
Research Site — Santa Maria, Brazil
Research Site — São Paulo, Brazil
Research Site — Vitória, Brazil
Research Site — Edmonton, Alberta, Canada
Research Site — Abbotsford British Columbia, British Columbia, Canada
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Research Site — Winnipeg, Manitoba, Canada
Research Site — Moncton, New Brunswick, Canada
Research Site — Barrie, Ontario, Canada
Research Site — Brampton, Ontario, Canada
Research Site — Ottawa, Ontario, Canada
Research Site — Sault Ste. Marie, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Montreal, Quebec, Canada
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Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Changde, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Chongqing, China
Research Site — Fuzhou, China
Research Site — Fuzhou, China
Research Site — Guangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Harbin, China
Research Site — Hefei, China
Research Site — Hohhot, China
Research Site — Jinan, China
Research Site — Kunming, China
Research Site — Lanzhou, China
Research Site — Linhai, China
Research Site — Linyi, China
Research Site — Nanchang, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Nanjing, China
Research Site — Nanning, China
Research Site — Nantong, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shantou, China
Research Site — Shenyang, China
Research Site — Shenzhen, China
Research Site — Tianjin, China
Research Site — Wuhan, China
Research Site — Wuhan, China
Research Site — Xi'an, China
Research Site — Xiamen, China
Research Site — Xingtai, China
Research Site — Xuzhou, China
Research Site — Yinchuan, China
Research Site — Zhengzhou, China
Research Site — Bordeaux, France
Research Site — Caen, France
Research Site — Lyon, France
Research Site — Marseille, France
Research Site — Rennes, France
Research Site — Villejuif, France
Research Site — Augsburg, Germany
Research Site — Bad Saarow, Germany
Research Site — Berlin, Germany
Research Site — Bonn, Germany
Research Site — Dresden, Germany
Research Site — Essen, Germany
Research Site — Essen, Germany
Research Site — Frankfurt, Germany
Research Site — Freiburg im Breisgau, Germany
Research Site — Hamburg, Germany
Research Site — Heidelberg, Germany
Research Site — Heilbronn, Germany
Research Site — Leipzig, Germany
Research Site — Lichtenberg, Germany
Research Site — Lübeck, Germany
Research Site — Magdeburg, Germany
Research Site — Mainz, Germany
Research Site — Mannheim, Germany
Research Site — Marburg, Germany
Research Site — Minden, Germany
Research Site — Moers, Germany
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Research Site — Stuttgart, Germany
Research Site — Ulm, Germany
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Debrecen, Hungary
Research Site — Győr, Hungary
Research Site — Gyula, Hungary
Research Site — Nyíregyháza, Hungary
Research Site — Pécs, Hungary
Research Site — Zalaegerszeg, Hungary
Research Site — Ahmedabad, India
Research Site — Bhubaneswar, India
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Research Site — Kolkata, India
Research Site — Mohali, India
Research Site — Mohali, India
Research Site — Mumbai, India
Research Site — New Delhi, India
Research Site — New Delhi, India
Research Site — Varanasi, India
Research Site — Vijayawada, India
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Research Site — Meldola, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
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Research Site — Rozzano, Italy
Research Site — Tricase, Italy
Research Site — Bunkyō City, Japan
Research Site — Chūōku, Japan
Research Site — Hirakata-shi, Japan
Research Site — Hiroshima, Japan
Research Site — Kashiwa, Japan
Research Site — Kitaadachi-gun, Japan
Research Site — Kōtoku, Japan
Research Site — Kurashiki-shi, Japan
Research Site — Nagoya, Japan
Research Site — Niigata, Japan
Research Site — Osaka, Japan
Research Site — Osaka, Japan
Research Site — Ota-shi, Japan
Research Site — Sagamihara-shi, Japan
Research Site — Sakai, Japan
Research Site — Sendai, Japan
Research Site — Shimotsuke-shi, Japan
Research Site — Sunto-gun, Japan
Research Site — Yokohama, Japan
Research Site — Yokohama, Japan
Research Site — George Town, Malaysia
Research Site — Kota Bharu, Malaysia
Research Site — Kota Kinabalu, Malaysia
Research Site — Kuala Lumpur, Malaysia
Research Site — Kuching, Malaysia
Research Site — Petaling Jaya, Malaysia
Research Site — Petaling Jaya, Malaysia
Research Site — Amsterdam, Netherlands
Research Site — Groningen, Netherlands
Research Site — Rotterdam, Netherlands
Research Site — Tilburg, Netherlands
Research Site — Gdansk, Poland
Research Site — Koszalin, Poland
Research Site — Krakow, Poland
Research Site — Lublin, Poland
Research Site — Olsztyn, Poland
Research Site — Warsaw, Poland
Research Site — San Juan, Puerto Rico
Research Site — Daegu, South Korea
Research Site — Hwasun-gun, South Korea
Research Site — Seongnam-si, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Madrid, Spain
Research Site — Pamplona, Spain
Research Site — Santander, Spain
Research Site — Santiago de Compostela, Spain
Research Site — Valencia, Spain
Research Site — Kaohsiung City, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Tainan, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Dusit, Thailand
Research Site — Hat Yai, Thailand
Research Site — Khon Kaen, Thailand
Research Site — Muang, Thailand
Research Site — Muang, Thailand
Research Site — Ankara, Turkey (Türkiye)
Research Site — Antalya, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Medreseboğazı, Turkey (Türkiye)
Research Site — Şahinbey, Turkey (Türkiye)
Research Site — Cambridge, United Kingdom
Research Site — Dundee, United Kingdom
Research Site — Leeds, United Kingdom
Research Site — London, United Kingdom
Research Site — Manchester, United Kingdom
Research Site — Oxford, United Kingdom
Research Site — Da Nang, Vietnam
Research Site — Hanoi, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Hồ Chí Minh, Vietnam
Research Site — Vinh, Vietnam

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