NCT03374007

Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma

With Open, Single/Multiple Dosing and Dose Escalation, Phase I Clinical Trial Scheme to Evaluate Safety, Tolerance and Pharmacokinetic Properties of Genolimzumab Injection

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Advanced Solid Tumor
• Recurrent Solid Tumor
• Lymphoma
• Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Geptanolimab Injection 1mg/kg	single-dose:1mg/kg
BIOLOGICAL	Geptanolimab Injection 3mg/kg	single-dose: 3mg/kg
BIOLOGICAL	Geptanolimab Injection 10mg/kg	single-dose:10mg/kg
BIOLOGICAL	Geptanolimab Injection 1mg/kg, q2w*6	multiple dosing: 1mg/kg, q2w\*6
BIOLOGICAL	Geptanolimab Injection 3mg/kg, q2w*6	multiple dosing: 3mg/kg, q2w\*6
BIOLOGICAL	Geptanolimab Injection 10mg/kg, , q2w*6	multiple dosing: 10mg/kg, , q2w\*6
BIOLOGICAL	Geptanolimab Injection 280mg, q3w	multiple dosing: 280mg, q3w
BIOLOGICAL	Geptanolimab Injection 3mg/kg, q2w	multiple dosing: 3mg/kg, q2w

Timeline

• Start date: 2017-10-19
• Primary completion: 2022-06-01
• Completion: 2022-08-01
• First posted: 2017-12-14
• Last updated: 2021-08-16

Locations

2 sites across 1 country: China