RecruitingPhase 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 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)

Sponsor

AstraZeneca

Enrollment

2,130 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Gastric Cancer Gastroesophageal Junction Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug combination for people with advanced or spreading stomach, junction, or esophageal cancer that expresses a protein called Claudin 18.2. You may be eligible if... - You are 18 or older with untreated advanced stomach, gastroesophageal junction, or lower esophageal cancer - Your cancer tests positive for a protein called Claudin 18.2 - You have reasonably good overall health (ECOG performance status 0 or 1) - Your organs (kidneys, liver, blood) are functioning well enough for treatment - You weigh at least 35 kg You may NOT be eligible if... - Your cancer is HER2-positive - You have significant active autoimmune disease, uncontrolled stomach bleeding, or serious fluid buildup in your lungs or abdomen - You have significant nerve damage or cancer spread to the brain - You have poorly controlled diabetes or active hepatitis - You are known to lack a certain liver enzyme (DPD) that processes one of the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSonesitatug vedotin

Intravenous

DRUGRilvegostomig

Intravenous

DRUGNivolumab

Intravenous

DRUGCapecitabine

Oral

DRUG5-Fluorouracil

Intravenous

DRUGOxaliplatin

Intravenous

DRUGZolbetuximab

Intravenous

DRUGLeucovorin

Intravenous

Locations(258)

Research Site

Phoenix, Arizona, United States

Research Site

Springdale, Arkansas, United States

Research Site

Duarte, 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

Denver, Colorado, United States

Research Site

Lone Tree, Colorado, United States

Research Site

New Haven, Connecticut, United States

Research Site

Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

Research Site

Fort Myers, Florida, United States

Research Site

Jacksonville, Florida, United States

Research Site

St. Petersburg, Florida, United States

Research Site

West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

Research Site

Atlanta, Georgia, United States

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Atlanta, Georgia, United States

Research Site

Macon, Georgia, United States

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Newnan, Georgia, United States

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Chicago, Illinois, United States

Research Site

Niles, Illinois, United States

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Zion, Illinois, United States

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Indianapolis, Indiana, United States

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Waukee, Iowa, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Burnsville, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Camden, New Jersey, United States

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East Brunswick, New Jersey, United States

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Hackensack, New Jersey, United States

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Summit, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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White Plains, New York, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Sherman, Texas, United States

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Blacksburg, Virginia, United States

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Fairfax, Virginia, United States

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Falls Church, Virginia, United States

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Fort Belvoir, Virginia, United States

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Richmond, Virginia, United States

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Olympia, Washington, United States

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Seattle, Washington, United States

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Charleston, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Darlinghurst, Australia

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Garran, Australia

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Heidelberg, Australia

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Murdoch, Australia

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Randwick, Australia

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Westmead, Australia

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Linz, Austria

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Rankweil, Austria

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Vienna, Austria

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Wiener Neustadt, Austria

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Brussels, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Barretos, Brazil

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Fortaleza, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Salvador, Brazil

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Santa Maria, Brazil

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São Paulo, Brazil

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Vitória, Brazil

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Edmonton, Alberta, Canada

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Abbotsford British Columbia, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Brampton, Ontario, Canada

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Ottawa, Ontario, Canada

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Sault Ste. Marie, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Changde, China

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Chengdu, China

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Chongqing, China

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Fuzhou, China

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Fuzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Hohhot, China

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Jinan, China

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Kunming, China

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Lanzhou, China

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Linhai, China

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Linyi, China

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Nanchang, China

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Nanchang, China

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Nanjing, China

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Nanjing, China

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Nanning, China

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Nantong, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shantou, China

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Shenyang, China

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Shenzhen, China

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Tianjin, China

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Wuhan, China

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Wuhan, China

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Xi'an, China

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Xiamen, China

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Xingtai, China

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Xuzhou, China

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Yinchuan, China

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Zhengzhou, China

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Bordeaux, France

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Caen, France

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Lyon, France

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Marseille, France

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Rennes, France

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Villejuif, France

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Augsburg, Germany

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Berlin, Germany

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Bonn, Germany

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Essen, Germany

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Frankfurt, Germany

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Freiburg im Breisgau, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Heilbronn, Germany

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Leipzig, Germany

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Mainz, Germany

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Mannheim, Germany

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Moers, Germany

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München, Germany

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Stuttgart, Germany

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Ulm, Germany

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Győr, Hungary

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Gyula, Hungary

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Nyíregyháza, Hungary

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Pécs, Hungary

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Zalaegerszeg, Hungary

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Ahmedabad, India

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Bhubaneswar, India

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Hyderabad, India

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Mohali, India

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Mumbai, India

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New Delhi, India

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New Delhi, India

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Varanasi, India

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Vijayawada, India

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Meldola, Italy

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Milan, Italy

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Milan, Italy

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Milan, Italy

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Padova, Italy

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Rozzano, Italy

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Tricase, Italy

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Chūōku, Japan

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Hirakata-shi, Japan

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Kashiwa, Japan

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Kitaadachi-gun, Japan

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Kōtoku, Japan

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Kurashiki-shi, Japan

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Nagoya, Japan

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Niigata, Japan

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Osaka, Japan

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Ota-shi, Japan

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Sakai, Japan

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Sendai, Japan

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Sunto-gun, Japan

Research Site

Yokohama, Japan

Research Site

Yokohama, Japan

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Groningen, Netherlands

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Rotterdam, Netherlands

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Tilburg, Netherlands

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Gdansk, Poland

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Koszalin, Poland

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Krakow, Poland

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Lublin, Poland

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Olsztyn, Poland

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Warsaw, Poland

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San Juan, Puerto Rico

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Daegu, South Korea

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Hwasun-gun, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Madrid, Spain

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Pamplona, Spain

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Santander, Spain

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Santiago de Compostela, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

Research Site

Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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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

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Leeds, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07431281

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