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
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