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

International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus

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.

Inclusion Criteria:

• Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology
• CLDN18.2 expression of the biopsy material from the cancer confirmed by immunohistochemistry
• At least 1 measurable site of disease according to RECIST criteria

Exclusion Criteria:

• Less than 3 weeks since prior chemo-or radiation therapy
• Other concurrent anticancer therapies
• Concurrent anticoagulation with vitamin K antagonists
• Therapeutic doses of Heparin (prophylactic doses accepted)
• Uncontrolled or severe illness