Phase I Clinical Study of Safety，Tolerability， Pharmacokinetics and Pharmacodynamics of Recombinant Humanized Cytotoxic T Lymphocyte Antigen 4 Single Domain Antibody Fc Fusion Protein Injection in Subjects With Advanced Solid Tumors

This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN044 in participants with all advanced solid tumors who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of KN044 as a single agent in adult participants with advanced solid tumors.

开始日期2020-01-09

申办/合作机构

长春钻智制药有限公司

100 项与重组人源化CTLA-4单域抗体Fc融合蛋白(Suzhou Alphamab) 相关的临床结果

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100 项与重组人源化CTLA-4单域抗体Fc融合蛋白(Suzhou Alphamab) 相关的转化医学

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100 项与重组人源化CTLA-4单域抗体Fc融合蛋白(Suzhou Alphamab) 相关的专利（医药）

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项与重组人源化CTLA-4单域抗体Fc融合蛋白(Suzhou Alphamab) 相关的文献（医药）

1986-01-01·Mutagenesis3区 · 医学

Absence of genotoxic effects in cells exposed to four ketonucleoside derivatives

3区 · 医学

Article

作者: Antonakis, K. ; Alaoui-Jamali, M. A. ; Lasne, Cl. ; Chouroulinkov, I.

The relationship between the structure and genotoxic potential of four new cytostatic compounds--the ketonucleosides KN-35, KN-43, KN-44 and KN-3--was investigated in short-term in vitro assays of hypoxanthine-guanine phosphoribosyl transferase locus mutation in V79 cells, induction of chromosomal aberrations and sister chromatid exchanges on human lymphocytes, induction of chromosomal aberrations and micronuclei in V79 cells, and transformation of Syrian hamster embryo cells. None of the ketonucleosides induced mutagenic effects in any of the assays. Their failure to exhibit significantly genotoxic activity may be ascribed to the probable absence of any reaction between these drugs and the cellular DNA, and indicates that they act by some other mechanism which probably differs from the one observed with alkylating or intercalating antitumoural agents. This suggests that the cytotoxic activity of ketonucleosides cannot be related to genotoxicity.

100 项与重组人源化CTLA-4单域抗体Fc融合蛋白(Suzhou Alphamab) 相关的药物交易

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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
晚期恶性实体瘤	临床1期	中国	苏州康宁杰瑞生物科技有限公司	2020-01-09
晚期恶性实体瘤	临床1期	中国	长春钻智制药有限公司	2020-01-09
肿瘤	临床1期	中国	江苏康宁杰瑞生物制药有限公司	-