Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies

Exclusion Criteria

• •Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives (whichever is shortest) prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1.
• •Part 2 ONLY: Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is documented progression of the lesion following radiotherapy
• •Immunosuppressive or systemic hormonal therapy (\>10 mg daily prednisone equivalent) within 2 weeks prior to C1/D1 with exceptions
• •Use of hematopoietic growth factors within 2 weeks prior to C1/D1
• •Active second malignancy or history of another malignancy within the last 3 years, with allowed exceptions
• •Central nervous system (CNS) malignancies including:
• •1. Primary malignancies of the CNS
• •2. Known, untreated CNS or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS metastatic involvement for which treatment is required
• •Inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy
• •Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any prior surgical procedure
• •Non-healing wounds on any part of the body
• •Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to C1/D1, unless adequately treated and stable
• •Active uncontrolled bleeding or a known bleeding diathesis
• •Significant gastrointestinal abnormalities
• •Significant cardiovascular disease or condition
• •Abnormal hematologic, renal or hepatic function