Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07431281

PHASE3

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

View on ClinicalTrials.gov

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.

Official title: A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2130

Start Date

2026-02-03

Completion Date

2031-10-27

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Gastric Cancer Gastroesophageal Junction Adenocarcinoma Esophageal Cancer

Interventions

DRUG

Sonesitatug vedotin

Intravenous

DRUG

Rilvegostomig

Intravenous

DRUG

Nivolumab

Intravenous

DRUG

Capecitabine

Oral

DRUG

5-Fluorouracil

Intravenous

DRUG

Oxaliplatin

Intravenous

DRUG

Zolbetuximab

Intravenous

DRUG

Leucovorin

Intravenous

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

Locations (314)

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

Research Site

Richmond, Virginia, United States

Research Site

Edmonds, Washington, United States

Research Site

Issaquah, Washington, United States

Research Site

Olympia, Washington, United States

Research Site

Seattle, Washington, United States

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

And 214 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (314)