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

CTR20170128 / Active, not recruiting临床1期

随机双盲平行对照评价GB222与贝伐珠单抗在健康志愿者中单次给药的PK相似性的比较试验

主要目的：评价单次给药后GB222与贝伐珠单抗的主要药代动力学参数AUC0-t的相似性次要目的：观察单次给药后GB222与贝伐珠单抗的其他药代动力学参数（Cmax、AUC0-∞等）、免疫原性的相似性及安全性

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

BACKGROUND:

This 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 METHODS:

This 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%.

RESULTS:

The 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).

CONCLUSION:

GB222 was found to be comparable to bevacizumab in terms of PKs, safety, and immunogenicity for Chinese healthy males.

TRIAL REGISTRATION:

ChiCTR-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

10 条进展最快的记录,

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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	临床1期	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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分期

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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	築襯遞構餘襯選簾壓範(襯蓋壓糧膚淵憲醖繭廠) = 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 夢廠壓襯鑰鹽膚選齋憲 (築觸遞鹽鏇壓積顧積襯 ) 更多	-	2021-09-25
CSCO2020	临床1期	胶质瘤	16	GB222 3mg/kg	鹽願廠積獵選構鏇夢餘(糧選範簾獵糧積範夢鏇) = 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淵廠鹹襯鏇壓窪膚獵選 (醖鹽遞鑰糧鹽膚壓積夢 ) 更多	-	2020-09-19