drugset / Trial / NCT00909025

Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer

NCT00909025

Phase 1 Completed 15 enrolled Ganymed Pharmaceuticals GmbH
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

EvaluationDrugModalityDoseRoute
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

Indications