GLOW
Research type
Research Study
Full title
A Phase 3, Global, Multi-Centre, Double-Blind, Randomised, Efficacy 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
IRAS ID
253195
Contact name
Minal Kara
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc. (APGD)
Eudract number
2018-000519-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
129598, IND
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Gastric (stomach) and gastroesophageal junction (GEJ; junction between food pipe and stomach) cancer is the fourth leading cause of cancer death worldwide. In 2017, an estimated 723,100 people died worldwide from gastric cancer. The investigational drug Zolbetuximab (IMAB362) is a genetically engineered antibody targeting a gastric cancer specific protein called Claudin 18.2 (CLDN 18.2). Zolbetuximab is currently being studied as a potential treatment for patients with advanced gastric and GEJ cancer.\nThe aim of the study is to collect information to determine if Zolbetuximab is a safe and effective gastric and GEJ cancer treatment in combination with the currently approved chemotherapy treatment called CAPOX.\nParticipants in the study will be randomly (by chance) assigned into two treatment groups:\n•\tStudy Treatment Group A: CAPOX chemotherapy in combination with Zolbetuximab\n•\tStudy Treatment Group B: CAPOX chemotherapy in combination with placebo\nThis is a double-blind randomised placebo-controlled study meaning neither the participant nor the study doctor will know the treatment group assignments.\nAstellas Pharma Global Development Inc is the sponsor of this global study with approximately 500 participants to be recruited worldwide. \n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0039
Date of REC Opinion
20 May 2019
REC opinion
Further Information Favourable Opinion