单位：[1]Sun Yat Sen Univ, Sun Yat Sen Univ Canc Ctr, Collaborat Innovat Ctr Canc Med, Dept Clin Res,State Key Lab Oncol South China, Guangzhou 510060, Peoples R China[2]Sun Yat Sen Univ, Sun Yat Sen Univ Canc Ctr, Collaborat Innovat Ctr Canc Med, Dept Med Oncol,State Key Lab Oncol South China, Guangzhou 510060, Peoples R China[3]Chinese Acad Med Sci, Res Unit Precis Diag & Treatment Gastrointestinal, Guangzhou 510060, Peoples R China[4]Zhengzhou Univ, Henan Canc Hosp, Affiliated Canc Hosp, Dept Oncol, Zhengzhou, Peoples R China河南省肿瘤医院[5]Harbin Med Univ Canc Hosp, Dept Gastrointestinal Med Oncol, Harbin, Peoples R China[6]Sun Yat Sen Univ, Sun Yat Sen Univ Canc Ctr, Collaborat Innovat Ctr Canc Med, State Key Lab Oncol South China,Bioinformat Platfo, Guangzhou 510060, Peoples R China[7]Huazhong Univ Sci & Technol, Tongji Hosp, Dept Med Oncol, Tongji Med Coll, Wuhan, Peoples R China肿瘤科华中科技大学同济医学院附属同济医院[8]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Canc Ctr, Wuhan, Peoples R China华中科技大学同济医学院附属协和医院[9]Novocodex Biopharmaceut, Shaoxing, Peoples R China
ARX788 is an anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugate with AS269 as cytotoxic payload. In this phase 1 multicenter dose-expansion clinical trial, patients with HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma failing to respond to prior trastuzumab-based standard treatment were enrolled. Between July 15th, 2019, and March 14th, 2022, 30 participants were enrolled. Twenty-eight (93.3%) patients experienced at least one drug-related adverse event (AE) and 13.3% experienced grade 3 ARX788-related AEs. The confirmed objective response rate is 37.9% (95% confidence interval [CI]: 20.7%-57.7%) and the disease control rate is 55.2% (95% CI: 35.7%-73.6%). With a median follow up of 10 months, the median progression-free survival and overall survival are 4.1 (95% CI: 1.4-6.4) and 10.7 months (95% CI: 4.8-not reached), respectively. The median duration of response is 8.4 (95% CI: 2.1-18.9) months. ARX788 is well tolerated and has promising anti-tumor activity in patients with HER2-positive advanced gastric adenocarcinoma (ChinaDrugTrials.org.cn: CTR20190639).
基金：
Novocodex Biopharmaceuticals; National Natural Science Foundation of China [82073377, 81772587, 82172861]; Natural Science Foundation of Guangdong [2021A1515012439, 2021A1515011743]; Science and Technology Program of Guangdong [2019B020227002]; CAMS Innovation Fund for Medical Sciences (CIFMS) [2019-I2M-5-036]
第一作者单位：[1]Sun Yat Sen Univ, Sun Yat Sen Univ Canc Ctr, Collaborat Innovat Ctr Canc Med, Dept Clin Res,State Key Lab Oncol South China, Guangzhou 510060, Peoples R China
通讯作者：
通讯机构：[2]Sun Yat Sen Univ, Sun Yat Sen Univ Canc Ctr, Collaborat Innovat Ctr Canc Med, Dept Med Oncol,State Key Lab Oncol South China, Guangzhou 510060, Peoples R China[3]Chinese Acad Med Sci, Res Unit Precis Diag & Treatment Gastrointestinal, Guangzhou 510060, Peoples R China
推荐引用方式(GB/T 7714)：
Zhang Yang,Qiu Miao-Zhen,Wang Ju-Feng,et al.Phase 1 multicenter, dose-expansion study of ARX788 as monotherapy in HER2-positive advanced gastric and gastroesophageal junction adenocarcinoma[J].CELL REPORTS MEDICINE.2022,3(11):doi:10.1016/j.xcrm.2022.100814.
APA：
Zhang, Yang,Qiu, Miao-Zhen,Wang, Ju-Feng,Zhang, Yan-Qiao,Shen, Ao...&Xu, Rui-Hua.(2022).Phase 1 multicenter, dose-expansion study of ARX788 as monotherapy in HER2-positive advanced gastric and gastroesophageal junction adenocarcinoma.CELL REPORTS MEDICINE,3,(11)
MLA：
Zhang, Yang,et al."Phase 1 multicenter, dose-expansion study of ARX788 as monotherapy in HER2-positive advanced gastric and gastroesophageal junction adenocarcinoma".CELL REPORTS MEDICINE 3..11(2022)
医学