Trastuzumab has been widely used among the breast cancer patients with human epidermal growth factor receptor\n2 (HER2) overexpression. The genetically engineered trastuzumab traded as Cipterbin�® was developed in China since\n2003. We have disclosed the phase I clinical trial data of safety, pharmacokinetic profile (PK) in patients with metastasis\nbreast cancer. Subjects identified as HER2 strong positive received single intravenously doses of 100, 250 or 500 mg\nCipterbin�® in dose-escalation manner. The safety evaluations were recorded and plasma concentration profiles for\nthe drug were analyzed. 27 Chinese metastatic breast cancer patients were enrolled in this study. Patients in each\ngroup of different dosage were well-tolerated. The most frequently drug-related adverse events were fever (59.3 %),\ntransaminase increased (22.2 %), chills (18.5 %) and arrhythmia (18.5 %). Only one patient with severe adverse event\nwas observed in 250 mg group revealing brachycardia. PK profile analysis showed that sera steady concentration\ncould be reached in dose-proportional manner, except volume of distribution (Vd) and clearance (CL), which reached\npeak values at 250 mg administration cohort. This genetically engineered HER2-target antibody had demonstrated\nthe accepted safety with well-tolerated.
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