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The antibody-drug conjugate SHR-A1904 for targeting CLDN18.2 in advanced gastric or gastroesophageal junction cancer: a phase 1 trial.

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Title: The antibody-drug conjugate SHR-A1904 for targeting CLDN18.2 in advanced gastric or gastroesophageal junction cancer: a phase 1 trial.
Authors: Ruan DY; Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China.; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China., Wu HX; Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China.; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China., Luo SX; Phase I Clinical Research Center, Henan Cancer Hospital, Zhengzhou, China., Huang WW; Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China.; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China., Liang XJ; Department of Abdominal Oncology, Hubei Cancer Hospital, Wuhan, China., Niu ZX; Department of Medical Oncology, Cancer Hospital of Shandong First Medical University, Ji'nan, China., Dang Q; Phase I Clinical Research Center, Cancer Hospital of Shandong First Medical University, Ji'nan, China., Li HL; Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China., Pan ZY; Department of Integrated Chinese and Western Medicine, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China., Lu HX; Department of Gastroenterology, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, China., Zhang YQ; Department of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China., Li XY; Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China., Xiao XY; Department of Medical Oncology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Cai SR; Department of Gastrointestinal Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China., Dong YG; Phase I Clinical Trial Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China., Zhang J; Department of Oncology, ZhuJiang Hospital of Southern Medical University, Guangzhou, China., Li Z; Department of General Surgery, ZhuJiang Hospital of Southern Medical University, Guangzhou, China., Lan HT; Department of Medical Oncology, Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital, Chengdu, China., Wang X; Department of Gastrointestinal Surgery, Peking University First Hospital, Beijing, China., Zhou Y; Department of Pharmacy & Drug Clinical Trial Institution, Peking University First Hospital, Beijing, China., Liu L; Department of Medical Oncology, Qilu Hospital of Shandong University, Ji'nan, China., Liu HL; Department of Gastrointestinal Surgery, Xiangya Hospital Central South University, Changsha, China., Xu PS; Phase I Clinical Trial Research Center, Xiangya Hospital Central South University, Changsha, China., Suo AL; Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China., Jia RN; Department of Digestive Oncology, The First Affiliated Hospital of Henan University of Science & Technology, Luoyang, China., Li YQ; Department of Digestive Oncology, Cancer Hospital Affiliated to Guangxi Medical University, Nanning, China., Peng XD; Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China., Wang SC; Department of Clinical Pharmacology, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China., Yu AA; Department of Biometrics, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China., Xie J; Oncology Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China., Qiu MZ; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China. qiumzh@sysucc.org.cn.; Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China. qiumzh@sysucc.org.cn., Xu RH; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China. xurh@sysucc.org.cn.; Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China. xurh@sysucc.org.cn.
Source: Nature medicine [Nat Med] 2025 Sep; Vol. 31 (9), pp. 3037-3046. Date of Electronic Publication: 2025 Jul 16.
Publication Type: Journal Article; Clinical Trial, Phase I
Journal Info: Publisher: Nature Publishing Company Country of Publication: United States NLM ID: 9502015 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1546-170X (Electronic) Linking ISSN: 10788956 NLM ISO Abbreviation: Nat Med Subsets: MEDLINE
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  Data: The antibody-drug conjugate SHR-A1904 for targeting CLDN18.2 in advanced gastric or gastroesophageal junction cancer: a phase 1 trial.
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  Data: <searchLink fieldCode="AU" term="%22Ruan+DY%22">Ruan DY</searchLink>; Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China.; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China.<br /><searchLink fieldCode="AU" term="%22Wu+HX%22">Wu HX</searchLink>; Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China.; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China.<br /><searchLink fieldCode="AU" term="%22Luo+SX%22">Luo SX</searchLink>; Phase I Clinical Research Center, Henan Cancer Hospital, Zhengzhou, China.<br /><searchLink fieldCode="AU" term="%22Huang+WW%22">Huang WW</searchLink>; Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China.; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China.<br /><searchLink fieldCode="AU" term="%22Liang+XJ%22">Liang XJ</searchLink>; Department of Abdominal Oncology, Hubei Cancer Hospital, Wuhan, China.<br /><searchLink fieldCode="AU" term="%22Niu+ZX%22">Niu ZX</searchLink>; Department of Medical Oncology, Cancer Hospital of Shandong First Medical University, Ji'nan, China.<br /><searchLink fieldCode="AU" term="%22Dang+Q%22">Dang Q</searchLink>; Phase I Clinical Research Center, Cancer Hospital of Shandong First Medical University, Ji'nan, China.<br /><searchLink fieldCode="AU" term="%22Li+HL%22">Li HL</searchLink>; Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.<br /><searchLink fieldCode="AU" term="%22Pan+ZY%22">Pan ZY</searchLink>; Department of Integrated Chinese and Western Medicine, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.<br /><searchLink fieldCode="AU" term="%22Lu+HX%22">Lu HX</searchLink>; Department of Gastroenterology, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, China.<br /><searchLink fieldCode="AU" term="%22Zhang+YQ%22">Zhang YQ</searchLink>; Department of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.<br /><searchLink fieldCode="AU" term="%22Li+XY%22">Li XY</searchLink>; Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.<br /><searchLink fieldCode="AU" term="%22Xiao+XY%22">Xiao XY</searchLink>; Department of Medical Oncology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Cai+SR%22">Cai SR</searchLink>; 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Department of Pharmacy & Drug Clinical Trial Institution, Peking University First Hospital, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Liu+L%22">Liu L</searchLink>; Department of Medical Oncology, Qilu Hospital of Shandong University, Ji'nan, China.<br /><searchLink fieldCode="AU" term="%22Liu+HL%22">Liu HL</searchLink>; Department of Gastrointestinal Surgery, Xiangya Hospital Central South University, Changsha, China.<br /><searchLink fieldCode="AU" term="%22Xu+PS%22">Xu PS</searchLink>; Phase I Clinical Trial Research Center, Xiangya Hospital Central South University, Changsha, China.<br /><searchLink fieldCode="AU" term="%22Suo+AL%22">Suo AL</searchLink>; Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.<br /><searchLink fieldCode="AU" term="%22Jia+RN%22">Jia RN</searchLink>; Department of Digestive Oncology, The First Affiliated Hospital of Henan University of Science & Technology, Luoyang, China.<br /><searchLink fieldCode="AU" term="%22Li+YQ%22">Li YQ</searchLink>; Department of Digestive Oncology, Cancer Hospital Affiliated to Guangxi Medical University, Nanning, China.<br /><searchLink fieldCode="AU" term="%22Peng+XD%22">Peng XD</searchLink>; Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China.<br /><searchLink fieldCode="AU" term="%22Wang+SC%22">Wang SC</searchLink>; Department of Clinical Pharmacology, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Yu+AA%22">Yu AA</searchLink>; Department of Biometrics, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Xie+J%22">Xie J</searchLink>; Oncology Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Qiu+MZ%22">Qiu MZ</searchLink>; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China. qiumzh@sysucc.org.cn.; Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China. qiumzh@sysucc.org.cn.<br /><searchLink fieldCode="AU" term="%22Xu+RH%22">Xu RH</searchLink>; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China. xurh@sysucc.org.cn.; Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China. xurh@sysucc.org.cn.
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