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HER2-targeting antibody drug conjugate FS-1502 in HER2-expressing metastatic breast cancer: a phase 1a/1b trial

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收录情况： ◇ SCIE ◇ 自然指数

作者：
Li Qiao[1] * ; Cheng Ying[2] ; Tong Zhongsheng[3] ; Liu Yunjiang[4] ; Wang Xian[5] ; Yan Min[6] ; Chang Jianhua[7] ; Wang Shusen[8] ; Du Caiwen[9] ; Li Liang[9] ; Wu Chunjiao[2] ; Wang Mingxia[10] ; Wang Zhuo[5] ; Wu Zhuli[11] ; Wang Xingli[11] ; Jin Yongli[12] ; Diao Lei[12] ; Sun Yi[12] ; Zhang Yongjiao[12] ; Hui Ai-Min[13] ; Xu Binghe[14] ;
机构： [1]Department of Medical Oncology, State Key Laboratory, National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [2]Department of Oncology, Jilin Cancer Hospital, Changchun, China. [3]Department of Breast Medical Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [4]Department of Breast Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [5]Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. [6]Department of Breast Medicine, Henan Cancer Hospital, Zhengzhou, Henan, China. [7]Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, China. [8]Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China. [9]Department of Medical Oncology, Meizhou People's Hospital, Meizhou, Guangdong, China. [10]Department of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [11]Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., Shanghai, China. [12]Shanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China. [13]EnCureGen Pharma, Guangzhou, China. [14]Department of Medical Oncology, State Key Laboratory, National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
出处：
DOI： 10.1038/s41467-024-48798-w
ISSN：

摘要：
Currently approved HER2-targeting antibody-drug conjugates (ADCs) for HER2-positive breast cancer (BC) are associated with safety concerns. In this multicenter, single-arm, dose-escalation (phase 1a) and dose-expansion (phase 1b) phase 1 trial (NCT03944499), patients with HER2-expressing advanced solid tumors received FS-1502 (an anti-HER2 ADC) with a 3 + 3 design in phase 1a; patients with metastatic HER2-positive BC received FS-1502 at the recommended phase 2 dose (RP2D) in phase 1b. The primary end points were dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and RP2D for phase 1a and objective response rate (ORR) for phase 1b. A total of 150 patients with HER2-expressing solid tumors (n = 5) and BC (n = 145) were enrolled (female, n = 146, 97.3%). One DLT each was reported at 3.0 and 3.5 mg/kg; the MTD was not reached. The RP2D was 2.3 mg/kg once every 3 weeks. Five (3.3%) patients experienced pneumonitis; four (2.7%) had grade 3 reversible ocular events. Of 67 HER2-positive BC patients receiving the RP2D, the best ORR was 53.7% (95% CI, 41.1-66.0%), including PRs confirmed (confirmed ORR, 37.5%) and pending for confirmation. FS-1502 was well tolerated with limited ocular and pulmonary findings and demonstrated promising antitumor activity in HER2-positive BC patients.© 2024. The Author(s).

基金：
This study was funded by Shanghai Fosun Pharmaceutical Industrial DevelopmentCo., Ltd., and partly supported by theChinese Academy of Medical Sciences Innovation Fund for Medical Sciences (CIFMS: 2021- I2M-1-014 and 2022-I2M-2-002, received by B. X.). Medical writing and editorial support were provided by JingYi Lee, PhD, of Parexel and funded by Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.. Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., participated in the study design, data collection and analysis and manuscript writing.
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外文
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出版当年[2025]版：
大类 | 1 区 综合性期刊
小类 | 1 区 综合性期刊
最新[2025]版：
大类 | 1 区 综合性期刊
小类 | 1 区 综合性期刊
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无
最新[2023]版：
Q1 MULTIDISCIPLINARY SCIENCES

影响因子： 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, State Key Laboratory, National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Li Qiao,Cheng Ying,Tong Zhongsheng,et al.HER2-targeting antibody drug conjugate FS-1502 in HER2-expressing metastatic breast cancer: a phase 1a/1b trial[J].NATURE COMMUNICATIONS.2024,15(1):5158.doi:10.1038/s41467-024-48798-w.
APA：
Li Qiao,Cheng Ying,Tong Zhongsheng,Liu Yunjiang,Wang Xian...&Xu Binghe.(2024).HER2-targeting antibody drug conjugate FS-1502 in HER2-expressing metastatic breast cancer: a phase 1a/1b trial.NATURE COMMUNICATIONS,15,(1)
MLA：
Li Qiao,et al."HER2-targeting antibody drug conjugate FS-1502 in HER2-expressing metastatic breast cancer: a phase 1a/1b trial".NATURE COMMUNICATIONS 15..1(2024):5158

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