This clinical trial is for men and women age 18 and older with metastatic or locally advanced unresectable gastric or gastro-esophageal junction (GEJ) cancer whose tumors have high or intermediate CLDN18.2 expression.
The purpose of this study is to see if a medicine called zolbetuximab is both safe and effective as a treatment by itself and in combination with mFOLFOX6 for gastric cancer. mFOLFOX6 is currently approved by the U.S. Food and Drug Administration (FDA) and other regulatory authorities for the treatment of gastric cancer. Zolbetuximab is not an approved product by the U.S. FDA and/or any other regulatory authorities in other countries for any indication. The study drug (zolbetuximab) targets a gastric cancer specific protein named CLDN18.2 to help treat gastric cancer. Claudin 18.2 is a protein created by the CLDN18 gene and is often seen in gastric cancer. A specific lab test of your tissue is used to see if your gastric cancer has expression of the CLDN18.2 protein. The investigational lab test is called CLDN18 immunohistochemistry (IHC) companion diagnostic.