With open, single/ multiple dosing and dose escalation, phase I clinical trial scheme to evaluate safety, tolerance and pharmacokinetic properties of Genolimzumab injection in Chinese patients of advanced and (or) recurrent solid tumor/lymphoma
Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: GB226) is joint developed by Genor Biopharma Co. Ltd and Crown Bioscience,Inc., it is the reorganization of deoxyribonucleic acid (DNA) technology in the Chinese hamster ovary (CHO) cells express system expressed in a immunoglobulin G4 (IgG4) kappa type single resistance to predominate. GB226 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 GB226 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 GB226 is 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
72
single-dose:1mg/kg
single-dose: 3mg/kg
single-dose:10mg/kg
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGadverse event
adverse event
Time frame: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.
Serious Adverse Event
Serious Adverse Event
Time frame: all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.
Dose limiting Toxicity, DLT
Dose limiting Toxicity, DLT
Time frame: Day 1 to Day 28 after first dose
Maximum Tolerated Dose, MTD
Maximum Tolerated Dose, MTD
Time frame: Day 1 to Day 28 after first dose
AUC 0-t
AUC 0-t
Time frame: up to 12 weeks
C max
C max
Time frame: up to 12 weeks
AUC 0-∞
AUC 0-∞
Time frame: up to 12 weeks
T max
T max
Time frame: up to 12 weeks
Vd
Vd
Time frame: up to 12 weeks
Ke
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multiple dosing: 1mg/kg, q2w\*6
multiple dosing: 3mg/kg, q2w\*6
multiple dosing: 10mg/kg, , q2w\*6
multiple dosing: 280mg, q3w
multiple dosing: 3mg/kg, q2w
Ke
Time frame: up to 12 weeks
t 1/2
t 1/2
Time frame: up to 12 weeks
CL
CL
Time frame: up to 12 weeks
Anti-drug antibody, ADA
Anti-drug antibody, ADA
Time frame: up to 12 weeks
IFN-γ concentration
IFN-γ concentration
Time frame: up to 12 weeks
peripheral blood CD8+PD-1 receptor occupying ratio
peripheral blood CD8+PD-1 receptor occupying ratio
Time frame: up to 12 weeks