safety, tolerability and pharmacokinetics of recombinant anti-epidermal growth factor receptor(egfr) monoclonal antibody in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to determine whether sct200 is safe and tolerant in the treatment of metastatic colorectal cancer


Eligibility criteria:
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

Keywords: full human anti-egfr monoclonal antibody (sct200) ; metastatic colorectal cancer （mcrc）; escalating doses ; single dose and multiple doses; safety, tolerability and pharmacokinetics.