Safety, Tolerability and Pharmacokinetics of Recombinant Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody in Patients With Metastatic Colorectal Cancer

Inclusion Criteria: * aged from 18 to 70 years; * having histologically confirmed metastatic colorectal cancer; * having experienced previous treatment failures including fluoropyrimidine, irinotecan and oxaliplatine chemotherapy regiment; * having determined wild-type KRAS tumor; * having to have measurable or nonmeasurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected survival of at least ≥3 months; * adequate hematological, renal and liver functions: 1. Hematological function: white blood cell count of \>4.0×109/L; absolute neutrophil count of \>1.5×109/ L; platelet count of \>100×109/L; hemoglobin level of \>90.0 g/L; 2. Renal function: serum creatinine level of\<1.5×upper limit of normal (ULN); 3. Liver function: total bilirubin level of\<1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \<1.5×ULN; or \<5 × ULN for patients with liver metastases; * no other malignancies only if they had following malignancies , which were not required to treat or who had curative resection: cervical carcinoma in situ, the skin basal carcinoma or squamous cell carcinoma, bladder epithelial tumors, or only they had some malignancies requirement only surgical therapy and disease free survival≥5 years; * no serious nonmalignant diseases including hypertension, diabetes mellitus, coronary artery disease, and mental disorder. * not pregnant; or not lactating; or accepted birth control methods during the study; * signed an informed consent form which was approved by the institutional review board of the respective medical center . Exclusion Criteria: * had received EGFR target treatment including EGFR tyrosine kinase inhibitors(TKI), or anti- EGFR monoclonal antibody; * having to be at least 4 weeks beyond prior anticancer therapy (including corticosteroid , or nitrosourea or mitomycin within 6 weeks of study entry) or participating in other clinical trial, or have not recovered from significant toxicities of prior therapy; * chronic use of medication that could interfere with the assessment of drug-related toxicities or immunologic activity (high dose prednisone or high dose non-steroid anti-inflammatory medication); * had recent major surgery (within 28 days); * with symptomatically brain metastases (with the exception of clinically brain metastases stable and of no requirement further treatment); * with active infection requirement systemic antibiotics treatment; or serious cardiovascular disease;or with evidence of active hepatitis B or C infection; or with human immunodeficiency virus infection; * had acute pulmonary disorder; or interstitial pneumonia; or symptomatically chronic obstructive pulmonary disease (COPD) or with risk factors to COPD; * with eye inflammation or infection, or any risk factors who could lead to eye disease; * with a history of allergic reaction or protein product allergy including antibodies product; * pregnant, or lactating, or not accepted birth control methods including male patients. * had a history of alcohol or drugs addiction, or with any risk which may affect the patient's health evaluation or mantle state