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
The purpose of this study is to see if an experimental study drug, called IMAB362, is both safe and effective as a treatment in combination with the chemotherapy regimen mFOLFOX6 for gastric and gastroesophageal junction (GEJ) cancer. mFOLFOX6 is a combination of medications currently approved for the treatment of gastric and GEJ cancer. The study drug targets a protein present in gastric cancer to help treat gastric cancer. The study drug is not FDA-approved.
gastric and GEJ cancer
-18 years and older male or female
-Histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma
-Radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
18 - 120
Healthy Volunteers Needed
Duration of Participation
Participants will receive either the study drug or placebo every 3 weeks for a total of 8 treatments during the first 4 cycles of this study. In this study, each cycle lasts 42 days. Participants will also receive mFOLFOX6 every 2 weeks (for a total of 12 treatments) during the first 4 cycles of this study.
After the first 4 cycles on the study, participants will continue to receive the study drug or Placebo every 3 weeks. In addition, the investigator will determine if it is in the participants best interest to continue to receive mFOLFOX6 will be discontinued after 4 cycles (12 treatments) as it is only recommended for a total of 4 cycles (12 treatments). Participants will receive the study drug as long as their cancer does not get worse and they do not have bad side effects.
Knight Cancer Institute Clinical Trials
Astellas Pharma Global Development, Inc.