Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: F520) is joint developed by Shandong New Time Pharmaceutical Co., LTD., it is the reorganization of deoxyribonucleic acid (DNA) technology in the Chinese hamster ovary (CHO) cells express system expressed in a immunoglobulin G1 (IgG1) kappa type single resistance to predominate. F520 had the different new amino acid sequence and molecular structure compared with two marketed PD-1 monoclonal antibody injection and got the approval of China Food and Drug Administration (CFDA) for clinical trial.Pharmaceutical research indicated F520 cell strain had security source, production process is stable, quality can control, preparation stability, has good compatibility with packaging materials, it has the condition of industrialization, can prepare investigational medicinal product with safety, effective, and controlled quality for clinical research.Pharmacodynamics study show the targets and mechanisms of F520is clear, tumor suppression effect is obvious.Toxicology studies show this product in high doses with low toxic, and the toxic is reversible, the most common toxicity is specific to the drug action mechanism.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Biological: F520 single-dose:0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 200mg/times, 10mg/kg; multiple dosing: 1mg/kg, 3mg/kg, 200mg/times, 10mg/kg, treat every 2 weeks; multiple dosing: 3mg/kg, 200mg/times, treat every 3 weeks.
Shaohong Yin
Linyi, Shandong, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: 1.5 years
PD-1 receptor occupancy of blood
Time frame: 3 years
Objective Response Rate (ORR) by irRC/ RECIST 1.1/RANO/cheson2007
Time frame: 3 years
Disease Control Rate (DCR) by irRC/ RECIST 1.1/RANO/cheson2007
Time frame: 3 years
Maximum Plasma Concentration (Cmax) after single dose injection of Anti-PD-1 Monoclonal Antibody (mAb)
Time frame: 1.5years
Peak Time (Tmax) after single dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Area Under the Curve (AUC) after single dose injection of Anti-PD-1 mAb
Time frame: 1.5years
t1/2 after single dose injection of Recombinant Humanized Anti-PD-1 mAb
Time frame: 1.5years
Plasma clearance (CL) after single dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Apparent volume of distribution (V) after single dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Minimum Plasma Concentration (Cmin) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Average Plasma Concentration (Cavg) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1.5years
degree of fluctuation (DF) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Apparent volume of distribution of steady state (Vss) after multiple dose injection of Anti-PD-1 mAb
Time frame: 1.5years
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