Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group

Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group

The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.

Inclusion Criteria:

• histological confirmed diagnosis cancer
• symptomatic malignant ascites
• EpCAM positive tumor
• EOCG 0-2
• negative pregnancy

Exclusion Criteria:

• acute or chronic infection
• exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days
• previous treatment with mouse monoclonal antibodies
• known or suspected hypersensitivity to Removab or similar antibodies
• inadequate renal function
• inadequate hepatic function (AST, ALt, GTP,< x ULN; bilirubin <1.5xULN)
• Platelets > 80000 cells/mm3; absolute neutrophil count (ANC) < 1500 cells/mm3
• BMI < 17
• Patients with reduced nutritional status
• Ileus within the last 30 days
• Brain metastases in cancer history
• Pregnant and nursing women
• history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months
• inadequate respiratory function in option of investigator