A Study of of MORAb-004 in Subjects With Solid Tumors

Exclusion Criteria

• •Known central nervous system (CNS) tumor involvement or metastases.
• •Evidence of other active malignancy.
• •Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
• •Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
• •Presence of severe lung disease (In the absence of clinically apparent severe lung disease, no formal testing is necessary. In the presence of clinically severe lung disease, FEV1 must be \>60% in order for the subject to be eligible.)
• •Active serious systemic disease, including active bacterial or fungal infection.
• •Chronic inflammatory disorder, e.g., inflammatory bowel disease, active vasculitis.
• •Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment.
• •Breast-feeding, pregnant, or likely to become pregnant during the study.
• •Active hepatitis or human immunodeficiency virus (HIV) infection.
• •Subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or previously documented human anti-human antibody (HAHA).
• •Subjects with large ascites or pleural effusion (≥500 cc) based on results of most recent CT scan).
• •Chronic systemic anticoagulation therapy with warfarin or heparin