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

CLDN18.2-positive Adenocarcinoma of Esophagus Clinical Trial

Official title: A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX (Epirubicin, Oxaliplatin, Capecitabine) Regimen as First-Line Treatment of Patients With CLDN18.2-Positive Advanced Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adenocarcinoma
• CLDN18.2-positive Adenocarcinoma of Esophagus
• CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
• CLDN18.2-positive Gastric Adenocarcinoma

• NCT number: NCT01630083
• Study type: Interventional
• Source: Astellas Pharma Inc
• Status: Completed
• Phase: Phase 2
• Start date: July 19, 2012
• Completion date: January 31, 2019