A Study of Zolbetuximab Together with Pembrolizumab and Chemotherapy in Adults with Gastric Cancer
Research type
Research Study
Full title
A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive
IRAS ID
1011745
Contact name
Taisa Paluch-Kassenberg
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2024-519773-19
Clinicaltrials.gov Identifier
Research summary
This study is testing a new treatment for people with advanced stomach cancer or gastroesophageal junction (GEJ) cancer, which occurs where the food pipe (oesophagus) meets the stomach. The study focuses on patients whose cancer does not have a protein called HER2 (human epidermal growth factor receptor 2) but does have Claudin 18.2, a protein found in some cancer cells. The treatment being studied is zolbetuximab, a drug designed to attach to Claudin 18.2 and help the immune system attack cancer. This study will test whether zolbetuximab, when combined with pembrolizumab (a type of immunotherapy) and chemotherapy, is more effective than pembrolizumab and chemotherapy alone. The study will assess whether patients receiving zolbetuximab live longer than those receiving a placebo (a substance with no active drug), if the treatment helps slow or shrink tumours, how safe and well-tolerated the treatment is, and how the body processes zolbetuximab.
Adults with advanced stomach or GEJ cancer that cannot be removed by surgery or has spread to other parts of the body may be eligible. Participants must have the Claudin 18.2 protein in their tumour. People with certain other health conditions, such as severe infections or immune system disorders, cannot take part.
Participants will be randomly assigned to receive either zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. Treatment is given through an infusion (slow injection into a vein) over repeated cycles. Participants will have regular health checks, blood tests, and scans. They may receive pembrolizumab for up to two years and will be monitored even after stopping treatment. Possible side effects include nausea, vomiting, and anaemia. The study has strict safety measures to monitor participants and adjust treatment if necessary. A total of approximately 500 people will take part in this study coming from approximately 275 different study sites in 23 different countries.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0098
Date of REC Opinion
25 Jun 2025
REC opinion
Further Information Favourable Opinion