Spotlight
Research type
Research Study
Full title
A Phase 3, Global, Multi-Centre, Double-Blind, Randomised, Efficacy Study of 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
IRAS ID
244709
Contact name
Minal Kara
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc. (APGD)
Eudract number
2017-002567-17
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
129598, IND reference
Duration of Study in the UK
3 years, 1 months, 14 days
Research summary
Gastric (stomach) and gastroesophageal junction (GEJ) 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 IMAB362 is a genetically engineered antibody targeting a gastric cancer specific protein called Claudin 18.2 CLDN 18.2. IMAB362 is currently being studied as a potential treatment for patients with advanced gastric and GEJ cancer.
The aim of the study is to collect information to determine if IMAB362 is a safe and effective gastric and GEJ cancer treatment in combination with the currently approved chemotherapy treatment called mFOLFOX6.
Participants in the study will be randomly (by chance) assigned into two treatment groups:
• Study Treatment Group A: mFOLFOX6 chemotherapy in combination with IMAB362
• Study Treatment Group B: mFOLFOX6 chemotherapy in combination with Placebo
This is a double-blind randomised placebo controlled study meaning neither the participant nor the study doctor will know the treatment group assignments.
Astellas Pharma Global Development Inc is the sponsor of this global study with approximately 550 participants to be recruited worldwide.REC name
HSC REC B
REC reference
18/NI/0127
Date of REC Opinion
4 Sep 2018
REC opinion
Further Information Favourable Opinion