drugset
drugset / Trial / NCT01630083

Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

NCT01630083 ↗

Phase 2 Completed 252 enrolled Astellas Pharma Global Development, Inc.
RandomizedParallel-groupTreatment

Summary

The purpose of the trial is to assess the therapeutic effects and the safety profile of IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment for patients with advanced adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction compared to EOX alone. Furthermore, sufficient binding of IMAB362 to the target cells is necessary for antitumoral activity. Thus, two dose levels ensuring a serum level above the in vitro predicted clinical efficacy threshold will be investigated.

Timeline

Start
2012-07-19
Primary completion
2019-01-31
Completion
2019-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject zolbetuximab Monoclonal antibody 600 mg/m2 Intravenous
Subject zolbetuximab Monoclonal antibody 1000 mg/m2 Intravenous
Background Capecitabine Small molecule 625 mg/m2 Oral
Background Epirubicin Small molecule 50 mg/m2 Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications

esophageal adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma