An Open-label, Dose-escalated, Phase I Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetic Profiles of GB222 in Chinese Patients With Relapsed/Progressive High-grade Glioma

This study is designed to assess the safety and tolerability, pharmacokinetic profiles, immunogenicity of GB222 in Chinese patients with relapsed/progressive high-grade glioma; moreover, changes in cerebral edema, changes in KPS score from baseline, objective response rate (ORR), 4-month progression-free survival (PFS), overall survival (OS)will be evaluated. The dose reduction of hormone during continuous administration period will be observed.

Start Date16 Oct 2018

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

CTR20180047 / RecruitingPhase 1

开放、剂量递增、评估GB222在中国复发/进展型高级别脑胶质瘤患者中安全性、耐受性和药代动力学特征的I期临床试验

[Translation] An open-label, dose-escalation Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of GB222 in Chinese patients with recurrent/progressive high-grade brain glioma

安全性及耐受性；药代动力学特征；免疫原性；脑水肿变化、KPS评分相较于基线的改变、客观缓解率ORR、4个月无进展生存率、总生存期OS；观察继续用药期间激素减量情况

[Translation]

Safety and tolerability; pharmacokinetic characteristics; immunogenicity; changes in brain edema, changes in KPS scores compared to baseline, objective response rate (ORR), 4-month progression-free survival rate, and overall survival (OS); observe the reduction of hormones during continued medication

Start Date16 Oct 2018

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

NCT04175158 / Unknown statusPhase 1

A Randomized, Double-blind, Parallel-controlled Comparative Study to Evaluate the PK Pharmacokinetic Similarity After Single Administration of GB222 and Bevacizumab in Healthy Volunteers.

The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.

Start Date24 Apr 2017

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

100 Clinical Results associated with Bevacizumab biosimilar(Genor Biopharma Co., Ltd.)

100 Translational Medicine associated with Bevacizumab biosimilar(Genor Biopharma Co., Ltd.)

100 Patents (Medical) associated with Bevacizumab biosimilar(Genor Biopharma Co., Ltd.)

Literatures (Medical) associated with Bevacizumab biosimilar(Genor Biopharma Co., Ltd.)

01 Feb 2022·Expert Opinion on Biological TherapyQ3 · MEDICINE

Pharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trial

Q3 · MEDICINE

Article

Author: Song, Haifeng ; Fang, Yi ; Lv, Jie ; an, Youzhong ; Wang, Jiaxue ; Xia, Lin ; Wang, Bianzhen ; Zheng, Qingshan ; Shen, Tiantian ; Fan, Huaying ; Wang, Qian ; Rao, Huiying ; Liu, Gang ; Xie, Fan ; Dong, Wenliang ; Chen, Min ; Niu, Suping ; Xie, Zhenwei

BACKGROUNDThis study was conducted to compare the similarity of the pharmacokinetics (PKs), safety, and immunogenicity of GB222, a potential bevacizumab biosimilar, to that of reference bevacizumab in Chinese healthy males.RESEARCH DESIGN AND METHODSThis was a randomized, double-blind, single-dose, parallel-group clinical trial performed in 84 Chinese healthy males, who were randomly assigned to receive a single infusion dose of 1 mg/kg GB222 or bevacizumab with an 84-days follow-up. The primary endpoint was the area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration at time t (AUC_0-t). The second endpoints were the safety and immunogenicity evaluation. The PK bioequivalence was verified by the 90% confidence intervals (CIs) of the geometrical mean (GM) ratio for AUC_0-t falling within the bioequivalence margin, 80-125%.RESULTSThe PK profiles of GB222 and bevacizumab were comparable. The 90% CIs of GM ratio of GB222 to bevacizumab for AUC_0-t was within the pre-specified bioequivalence margin. The most common treatment-related adverse event was sinus bradycardia. Seventeen subjects (20.2%) tested positive for anti-drug antibodies (ADAs).CONCLUSIONGB222 was found to be comparable to bevacizumab in terms of PKs, safety, and immunogenicity for Chinese healthy males.TRIAL REGISTRATIONChiCTR-IIR-17,011,143.

100 Deals associated with Bevacizumab biosimilar(Genor Biopharma Co., Ltd.)

External Link

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	CN	Genor Biopharma Co., Ltd.	15 Dec 2017
High grade glioma	Phase 1	CN	Genor Biopharma Co., Ltd.	16 Oct 2018
Recurrent Malignant Glioma	Preclinical	CN	Genor Biopharma Co., Ltd.	16 Oct 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CSCO2021	Phase 1	Recurrent Glioma	16	GB222	(xalqbkvuww) = All patients (100%) reported experiencing at least one adverse event (TEAE) among patients who either received GB222 alone or the combination therapy of both GB222 and temozolomide hcysbvipeu (gmzjjuvljw ) View more	-	25 Sep 2021
CSCO2020	Phase 1	Glioma	16	GB222 3mg/kg	(uirsrhpkfj) = 共4例受试者发生7例次3级和4级AE，包括癫痫持续状态、骨髓功能衰竭、带状疱疹和血液学实验室检查值异常，均判定与药物无关或可能无关 ilspyyxsuo (jemkuomktt ) View more	-	19 Sep 2020

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