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Brief Title: Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer
Official Title: Clinical First-in-human Single-dose Escalation Study Evaluating the Safety and Tolerability of Claudiximab (iMAB-362) in Hospitalized Patients With Advanced Gastroesophageal Cancer. A Multi-center, Phase I, Open-label, i.v. Infusion Study
Study ID: NCT00909025
Brief 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
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsklinikum Essen, Innere Klinik (Tumorforschung), Essen, , Germany
Universität Heidelberg, Nationales Centrum fßr Tumorerkrankungen (NCT), Heidelberg, , Germany
Johannes Gutenberg Universität, 1.Med Klinik und Poliklinik, Mainz, , Germany
Klinikum Rechts-der-Isar, III.Medizinische Klinik und Poliklinik, MĂźnchen, , Germany
Piejuras Hospital, Liepaja, , Latvia
Pauls Stradins University, Riga, , Latvia
Name: Martin Schuler, Prof.Dr.med.
Affiliation: Innere Klinik (Tumorforschung) Universitätsklinikum Essen Hufelandstr. 55 45122 Essen, GERMANY
Role: PRINCIPAL_INVESTIGATOR