A Phase III Study of mFOLFOX6 with Zolbetuximab or Placebo as Initial Treatment of People with Inoperable or Metastatic Cancer of the Stomach or Gastroesophageal Junction

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Full Title

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (WIRB)

Purpose

The chemotherapy combination mFOLFOX6 is already used to treat patients with cancer of the stomach and the junction between the esophagus and stomach (gastroesophageal junction or GEJ). In this study, researchers want to see if adding zolbetuximab to mFOLFOX6 is more effective than mFOLFOX6 alone in patients with inoperable or metastatic stomach and GEJ cancers.

Zolbetuximab targets a protein called CLDN18.2, which is abundant on the surface of some cancer cells. Zolbetuximab may help recruit immune cells to act against CLDN18.2, resulting in cancer cell death. Researchers think that adding zolbetuximab to standard chemotherapy may make this treatment more effective in people with stomach and GEJ cancers that make the CLDN18.2 protein.

Patients in this study will be randomly assigned to receive mFOLFOX6 with zolbetuximab or mFOLFOX6 with a placebo (inactive drug). All of the medications in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic stomach or GEJ cancer that is positive for CLDN18.2.
  • Patients may not have received chemotherapy for advanced stomach or GEJ. Prior therapy for earlier stage cancer must have been completed more than 6 months before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Ilson at 646-888-4183.

Protocol

19-267

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators