A Phase 1/1b Study of ASP2138 in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression (Gastrointestinal Cancer)
Sponsor: |
Astellas Pharma Global Development Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU7688 |
U.S. Govt. ID: |
NCT05365581 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The goal of this study is to see if a study drug called ASP2138 is safe and effective for people diagnosed with tumors known to have Claudin (CLDN) 18.2 expression. CLDN is a group of proteins seen in gastric-specific, gastroesophageal junction (GEJ) or pancreatic cancer types. The study will also see how ASP2138 is processed in the blood. Each participant will complete a number of procedures and blood collections in order to find the best dose of ASP2138. When this dosage is identified, it will be used to evaluate if ASP2138 causes tumors to shrink. ASP2138 will be assessed continuously throughout the study to understand if it is safe and effective. This study is a first-in-human clinical trial. The Food and Drug Administration (FDA) in the United States of America has not approved ASP2138 for sale or for the treatment of cancer.
Investigator
Ryan Moy, MD
Are you at least 18 years old? |
Yes |
No |
Have you been diagnosed with with stomach or pancreatic cancer? |
Yes |
No |