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Study identifier: NCT06901531 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

Condition: Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer · Metastatic Gastric Adenocarcinoma or Cancer  ·  Sponsor: Astellas Pharma Global Development, Inc.

PhasePhase 3
Planned participants500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy. Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearb…

This description comes directly from the study's public registry record.

Talk to the study team

Astellas Pharma Global Development Inc.  ·  800-888-7704  ·  astellas.registration@astellas.com

Always discuss trial participation with your own doctor first.

Locations (249)

UAB Medicine - UAB HospitalBirmingham, Alabama, United StatesRecruiting
CBCC Global Research - Comprehensive Blood & Cancer CenterBakersfield, California, United StatesRecruiting
TOI Clinical ResearchCerritos, California, United StatesRecruiting
University of California, San Diego Moores Cancer CenterLa Jolla, California, United StatesRecruiting
The Angeles Clinic and Research Institute, West Los Angeles OfficeLos Angeles, California, United StatesRecruiting
Hartford HealthCare - Hartford HospitalHartford, Connecticut, United StatesRecruiting
Yale University School of MedicineNew Haven, Connecticut, United StatesRecruiting
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia, United StatesRecruiting
Piedmont Physician Medical Oncology AtlantaAtlanta, Georgia, United StatesRecruiting
Northwestern Memorial HospitalChicago, Illinois, United StatesRecruiting
Franciscan Health Oncology and Hematology SpecialistsIndianapolis, Indiana, United StatesRecruiting
Holden Comprehensive Cancer CenterIowa City, Iowa, United StatesRecruiting

+ 237 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06901531