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

Inclusion criteria

• Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology
• CLDN18.2 expression confirmed by immunohistochemistry
• Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel
• At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry)
• Age ≥ 18 years
• ECOG performance status (PS) 0-1 or Karnofsky Index 70-100%
• Life expectancy > 3 months
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dl
• INR < 1.5
• Bilirubin normal
• AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Creatinine < 1.5 x ULN

Exclusion criteria

• Pregnancy or breastfeeding
• Prior allergic reaction or intolerance to a monoclonal antibody
• Prior inclusion in the present study
• Less than 3 weeks since prior anti-tumor or radiation therapy
• Other investigational agents or devices concurrently or within 4 weeks prior to this study
• Other concurrent anticancer therapies
• History of positive test for human immunodeficiency virus (HIV) antibody
• Known Hepatitis.
• Uncontrolled or severe illness.
• Concurrent administration of anticoagulation agents with vitamin K antagonists
• Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)