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Also known as EMD 72000
Matuzumab · 1 trial · 2 indications
Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (\>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.
| Arm | Type | Description |
|---|---|---|
| Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | EXPERIMENTAL | - |
| ECX Only | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Matuzumab | DRUG | Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn. |
| Epirubicin | DRUG | Participants will receive epirubicin 50 milligrams per square meter (mg/m\^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles. |
| Cisplatin | DRUG | Participants will receive cisplatin 60 mg/m\^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles. |
| Capecitabine | DRUG | Participants will receive capecitabine 1250 mg/m\^2 daily in a 21-day cycles up to a maximum of 8 cycles. |
Inclusion Criteria: * Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus * Metastatic disease * Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from archived tissues * Eastern Cooperative Oncology Group Performance...
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Matuzumab is an investigational monoclonal antibody that has been studied in esophageal and gastric cancer. It was evaluated in a Phase 2 trial in combination with epirubicin, cisplatin and capecitabine (ECX) chemotherapy for esophago-gastric cancer. It is not an approved therapy and remains in clinical development.
Matuzumab targets EGFR, the epidermal growth factor receptor. It is a monoclonal antibody that acts as an EGFR inhibitor, binding to the receptor to block signaling that supports tumor cell growth. This mechanism was the basis for its study in EGFR-expressing esophago-gastric cancers.
Matuzumab was developed by Merck KGaA, which trades over the counter in the United States under the ticker MKGAF. The company sponsored the Phase 2 trial of matuzumab in esophago-gastric cancer. No other developer is associated with the asset in the available records.
Matuzumab is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved for any indication. Its clinical program in esophago-gastric cancer has not advanced beyond this completed Phase 2 study.
Matuzumab was studied in one completed Phase 2 trial, NCT00215644, titled Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer. The trial enrolled 72 patients across Germany, Spain, Switzerland and the United Kingdom and used an active-controlled, randomized design.