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.

开始日期2018-10-16

申办/合作机构

嘉和生物药业有限公司

CTR20180047 / Recruiting临床1期

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

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

开始日期2018-10-16

申办/合作机构

嘉和生物药业有限公司

NCT04175158 / Unknown status临床1期

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.

开始日期2017-04-24

申办/合作机构

嘉和生物药业有限公司

100 项与贝伐珠单抗生物类似药 (嘉和生物) 相关的临床结果

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100 项与贝伐珠单抗生物类似药 (嘉和生物) 相关的转化医学

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100 项与贝伐珠单抗生物类似药 (嘉和生物) 相关的专利（医药）

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项与贝伐珠单抗生物类似药 (嘉和生物) 相关的文献（医药）

2022-02-01·Expert Opinion on Biological Therapy3区 · 医学

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

3区 · 医学

Article

作者: Song, Haifeng ; Fang, Yi ; an, Youzhong ; Lv, Jie ; 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 项与贝伐珠单抗生物类似药 (嘉和生物) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌	临床3期	中国	嘉和生物药业有限公司	2017-12-15
高级别胶质瘤	临床1期	中国	嘉和生物药业有限公司	2018-10-16
复发性恶性胶质瘤	药物发现	中国	嘉和生物药业有限公司	2018-10-16

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CSCO2021	临床1期	复发性胶质瘤	16	GB222	(構餘餘憲簾襯醖鏇鏇觸) = 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 鏇願網鹹網衊襯蓋積夢 (醖糧繭顧網衊選鑰網築 ) 更多	-	2021-09-25
CSCO2020	临床1期	胶质瘤	16	GB222 3mg/kg	(積鹽衊鬱襯鑰淵構顧遞) = 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築鹽鏇膚窪蓋襯夢膚淵 (膚鬱繭顧製構壓膚顧壓 ) 更多	-	2020-09-19