drugset / Trial / NCT00909025
Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer
NaSingle-groupOpen-labelOther
Summary
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma
Timeline
- Start
- 2009-05-31
- Primary completion
- 2010-05-31
- Completion
- 2010-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zolbetuximab | Monoclonal antibody | 33 mg/m2 | Intravenous |
| Subject | zolbetuximab | Monoclonal antibody | 100 mg/m2 | Intravenous |
| Subject | zolbetuximab | Monoclonal antibody | 300 mg/m2 | Intravenous |
| Subject | zolbetuximab | Monoclonal antibody | 600 mg/m2 | Intravenous |
| Subject | zolbetuximab | Monoclonal antibody | 1000 mg/m2 | Intravenous |