A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Phase 3
Active, not recruiting
NCT03504397
| 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 |
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| Phase | Phase 3 |
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| Sponsor | Astellas Pharma Global Development, Inc. |
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| Status | Active, not recruiting |
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| Enrollment | 565 participants |
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| Interventions | zolbetuximab, oxaliplatin, folinic acid, fluorouracil |
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| Start date | Jun 21, 2018 |
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| Completion date | Sep 9, 2022 |
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| Results posted | Feb 26, 2025 |
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Summary
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (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 gastric 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 study doctor wil
Progression Free Survival (PFS)
From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days) · Months
| mFOLFOX6 + Zolbetuximab | 11.04 Months |
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| mFOLFOX6+ Placebo | 8.94 Months |
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| p-value | 0.0024 |
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| Hazard Ratio (HR) | 0.734 (95% CI 0.591–0.910) |
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Open in BENITIONS
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