drugset / Trial / NCT01197885

Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer

NCT01197885

Phase 2 Completed 54 enrolled Ganymed Pharmaceuticals GmbH
NaSingle-groupOpen-labelTreatment

Summary

IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.

Timeline

Start
2010-09-03
Primary completion
2015-08-13
Completion
2015-08-13

Drugs

EvaluationDrugModalityDoseRoute
Subject zolbetuximab Monoclonal antibody 300 mg/m2 Intravenous
Subject zolbetuximab Monoclonal antibody 600 mg/m2 Intravenous

Indications