A Study of Zolbetuximab Given With mFOLFOX6 or CAPOX Chemotherapy in Indian Adults With Gastric Cancer
Summary
There is an unmet medical need to treat people with advanced cancer in the stomach and the junction area where the stomach joins the food pipe. These conditions are known as advanced or stomach (gastric) cancer and advanced gastroesophageal junction cancer (GEJ cancer for short). Zolbetuximab is an approved treatment in many countries for people with advanced stomach cancer and advanced GEJ cancer. Some people with these cancers have a protein called Claudin 18.2 on their tumor but they do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative). Zolbetuximab works by attaching to the Claudin 18.2 protein on their tumor. This switches on the body's immune system to attack the tumor. In India, the standard chemotherapies used are mFOLFOX6 or CAPOX. The main aim of the study is to check the safety of zolbetuximab when given with mFOLFOX6 or CAPOX chemotherapies in people in India with advanced stomach or GEJ cancer. It will also check how well zolbetuximab controls stomach cancer and GEJ cancer when given with mFOLFOX6 or CAPOX.
Timeline
- Start
- 2026-11-30
- Primary completion
- 2029-07-31
- Completion
- 2029-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zolbetuximab | Monoclonal antibody | 400 mg/m2 | — |
| Subject | zolbetuximab | Monoclonal antibody | 600 mg/m2 | — |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |