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Study identifier: NCT05365581 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer

Condition: Gastric Adenocarcinoma · Gastroesophageal Junction (GEJ) Adenocarcinoma · Pancreatic Adenocarcinoma  ·  Sponsor: Astellas Pharma Global Development, Inc.

PhasePhase 1
Planned participants398
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This "tells" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments. The main aims of the study are: * To check the safety of ASP2138 and how well people can tolerate medical problems during the study. * To find a suitable dose of ASP2138 to be used later in the study. * These are done for ASP2138 given by itself and when given together with the standard cancer treatments. Adults 18 years or ol…

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 (46)

University of California Irvine Medical CenterOrange, California, United StatesRecruiting
UCLA Dept of Medicine - Hematology/Oncology, Santa MonicaSanta Monica, California, United StatesWithdrawn
Northwestern UniversityChicago, Illinois, United StatesRecruiting
University of Kansas Cancer CenterWestwood, Kansas, United StatesRecruiting
Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey, United StatesCompleted
NYU Langone Medical Center - NYU Medical Oncology AssociatesNew York, New York, United StatesRecruiting
Columbia UniversityNew York, New York, United StatesActive Not Recruiting
Memorial Sloan Kettering Cancer CenterNew York, New York, United StatesRecruiting
Duke Children's Hospital and Health CenterDurham, North Carolina, United StatesRecruiting
Wake Forest University Baptist HealthWinston-Salem, North Carolina, United StatesRecruiting
UT Southwestern Medical CenterDallas, Texas, United StatesRecruiting
Virginia Mason Medical CenterSeattle, Washington, United StatesRecruiting

+ 34 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05365581