A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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 (GLOW).

Phase 3 Active, not recruiting NCT03653507

Condition	Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma
Phase	Phase 3
Sponsor	Astellas Pharma Global Development, Inc.
Status	Active, not recruiting
Enrollment	507 participants
Interventions	zolbetuximab, oxaliplatin, capecitabine
Start date	Nov 28, 2018
Completion date	Oct 25, 2022
Results posted	Jan 27, 2025

Summary

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called GEJ cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat stomach cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the people taking part in those countries will l

Progression Free Survival (PFS)

From the date of randomization until 61 months and 12 days · Months

CAPOX+ Zolbetuximab	8.21 Months
CAPOX+ Placebo	6.80 Months

p-value	0.0005
Hazard Ratio (HR)	0.689 (95% CI 0.552–0.860)

Open in BENITIONS View on ClinicalTrials.gov

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All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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