A phase I study of toripalimab, an anti-PD-1 antibody, in patients with refractory malignant solid tumors
作者机构：Department of Medical OncologyState Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineSun Yat-sen University Cancer CenterGuangzhouGuangdong 510060P.R.China Shanghai Junshi Biosciences Company LimitedShanghai 201203 P.R.China Precision Diagnosis and Treatment for Gastrointestinal CancerChinese Academy of Medical SciencesGuangzhouGuangdong 510060P.R.China
出 版 物：《Cancer Communications》 (癌症通讯（英文）)
年 卷 期：2020年第40卷第8期
页 面：345-354页
核心收录：
学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
基 金：sponsored by Shanghai Junshi Biosciences Co.,Ltd.and supported,in part,by National Key R&D Program of China(2018YFC1313300) Science and Technology Program of Guangdong(2019B020227002) CAMS Innovation Fund for Medical Sciences(2019-I2M-5-036) National Natural Science Foundation of China(81930065) Natural Science Foundation of Guangdong Province(2014A030312015) Science and Technology Program of Guangdong(2019B020227002) Science and Technology Program of Guangzhou(201904020046,201803040019,201704020228) Guangdong Basic and Applied Basic Research Foundation(2019A1515110171)
主 题：anti-PD-1 antibody toripalimab phase I study safety efficacy pharmacokinetics pharmacodynamics solid tumor
摘 要：Background:Several programmed cell death ligand 1(PD-L1)/programmed cell death protein 1(PD-1)antibodies have been approved for cancer *** pharmacokinetic and pharmacodynamic characteristics have been reported mainly in western countries,but related data in Chinese patients are *** study was conducted to investigate the safety,efficacy,pharmacokinetics,and pharmacodynamics of an anti-PD-1 antibody,toripalimab,in Chinese ***:A single-center phase I study was conducted in Sun Yat-sen University Cancer *** patients were adults with histologically confirmed,treatment-refractory,advanced,solitary malignant *** was intravenously infused every 2 weeks in dose-escalating cohorts at 0.3mg/kg,1 mg/kg,3 mg/kg,10 mg/kg,and 240 *** study followed standard 3+3 ***:Between 15th March 2016 and 27th September 2016,25 patients were enrolled,of whom 3(12.0%),7(28.0%),6(24.0%),6(24.0%),3(12.0%)received 0.3 mg/kg,1 mg/kg,3 mg/kg,10 mg/kg,and 240 mg toripalimab,*** a median follow-up time of 5.0 months(range:1.5-19.8 months),we observed that the commonest treatment-related adverse events(TRAEs)were fatigue(64.0%)and rash(24.0%).No grade 3 or higher TRAEs were *** dose-limiting toxicity,treatment-related serious adverse events(SAEs),or treatment-related death *** response ratewas 12.5%.The half-life of toripalimabwas 150-222 h after a single dose *** patients,including those from the 0.3 mg/kg group,maintained complete PD-1 receptor occupancy(80%)on activated T cells since receiving the first dose of ***:Toripalimab is a promising anti-PD-1 antibody,which was well tolerated and demonstrated anti-tumor activity in treatment-refractory advanced solitary malignant *** exploration in various tumors and combination therapies is warranted.
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