A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab/Payamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma
研究单位:[1]Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.[2]Fuyang Cancer Hospital,Fuyang,Anhui,China,23600[3]Peking Union Medical College Hospital,Beijing,Beijing,China,100730[4]The first affiliated hospital of chongqing medical university,Chongqing,Chongqing,China,400016[5]Fujian Cancer Hospital,Fuzhou,Fujian,China,350014[6]Gansu Prouincial Cancer Hospital,Lanzhou,Gansu,China,730000[7]Gansu Wuwei Tumour Hospital,Wuwei,Gansu,China,733099[8]Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China,510060[9]Nanfang Hospital,Guangzhou,Guangdong,China,510515[10]Jiangmen Central Hospital,Jiangmen,Guangdong,China,529000[11]Meizhou People''s Hospital,Meizhou,Guangdong,China,514031[12]The Second Affiliated Hospital of Guilin Medical College,Guilin,Guangxi,China,541004[13]Guangxi Medical University Cancer Hospital,Nanning,Guangxi,China,530021[14]The first affiliated hospital of hainan medical university,Haikou,Hainan,China,570102[15]The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050010[16]Tangshan People''s Hospital,Tangshan,Hebei,China,063001[17]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China,150081[18]Anyang Cancer Hospital,Anyang,Henan,China,455000[19]The 1st Affiliated Hospital of He''nan University of Science and Technology,Luoyang,Henan,China,471000[20]Puyang Oilfield General Hospital,Puyang,Henan,China,457001[21]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450000[22]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology,Wuhan,Hubei,China,430023[23]Xiangyang Central Hospital,Xiangyang,Hubei,China,441000[24]Hunan Cancer Hospital,Changsha,Hunan,China,410000[25]The Second Xiangya Hospital Of Central South University,Changsha,Hunan,China,410000[26]NanJing Drum Tower Hospital,Nanjing,Jiangsu,China,210000[27]Northern Jiangsu People''s Hospital,Yangzhou,Jiangsu,China,225009[28]Jilin Cancer Hospital,Changchun,Jilin,China,130012[29]Cancer Hospital of Shandong First Medical University,Jinan,Shandong,China,264000[30]Fudan university shanghai cancer center,Shanghai,Shanghai,China,200032[31]Renji Hospital, Shanghai Jiaotong University School of Medicine,Shanghai,Shanghai,China,200120[32]Shanxi Cancer hospital,Taiyuan,Shanxi,China,030000[33]The First Affiliated Hospital of Xi''an Jiao Tong University,Xi''an,Shanxi,China,710000[34]Nanchong Central Hospital,Nanchong,Sichuan,China,637000[35]Tianjin Medical University Cancer Institute & Hospital,Tianjin,Tianjin,China,300202[36]Xinjiang Medical University Affiliated Cancer Hospital,Ürümqi,Xinjiang,China,810000[37]Wenzhou Medical University Affiliated First Hospital,Wenzhou,Zhejiang,China,325000
研究目的:
TQB2102 for injection is a novel antibody-coupled drug (ADC) that enhances binding to tumor cell surface HER2 proteins by simultaneously targeting the two non-overlapping epitopes of the HER2 protein, Endothelial Cell Dysfunction 2 (ECD2) and Endothelial Cell Dysfunction 4 (ECD4), increasing HER2 internalization, and then down-regulating the tumor cell surface HER2 proteins more effectively, and doubly blocking the HER2 signaling, to achieve the effects of trastuzumab and Pertuzumab alone and in combination. This is a Phase II study to evaluate the efficacy and safety of TQB2102 for injection in combination with Benmelstobart Injection /Penpulimab Injection ± capecitabine in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma