[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549482":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":339,"collaborators":11,"id":341,"slug":342,"hasResults":343,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":11,"eligibilityCriteria":347,"healthyVolunteers":343,"sex":348,"minAge":349,"maxAge":11,"enrollmentInfo":350,"targetDuration":11,"studyType":353,"phases":354,"briefSummary":356,"conditions":357,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":368},{"fullName":5,"class":6},"Shanghai Pharmaceuticals Holding Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SPH5030","EXPERIMENTAL",null,[13],"Drug: SPH5030",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","SPH5030：Oral, QD, 600mg",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Jianming Xu","CONTACT","0086-010-66937166","jfjzyygw@163.com",[26,41,48,56,64,77,88,99,107,118,129,137,148,159,170,181,192,200,208,218,229,240,251,262,273,284,295,306,317,328],{"facility":27,"status":28,"city":29,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Beijing Friendship Hospital，Capital Medical University","RECRUITING","Beijing","China","CN",{"type":33,"coordinates":34},"Point",[35,36],116.39723,39.9075,{"lat":36,"lon":35},[39],{"name":40,"role":22,"phone":11,"phoneExt":11,"email":11},"Bangwei Cao",{"facility":42,"status":28,"city":29,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":43,"geoPoint":45,"contacts":46},"Chinese PLA General hospital",{"type":33,"coordinates":44},[35,36],{"lat":36,"lon":35},[47],{"name":21,"role":22,"phone":11,"phoneExt":11,"email":11},{"facility":49,"status":28,"city":29,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},"Peking Union Medical College Hospital",{"type":33,"coordinates":51},[35,36],{"lat":36,"lon":35},[54],{"name":55,"role":22,"phone":11,"phoneExt":11,"email":11},"Haitao Zhao",{"facility":57,"status":28,"city":29,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"The Second Affiliatedf Hospital of AFMU",{"type":33,"coordinates":59},[35,36],{"lat":36,"lon":35},[62],{"name":63,"role":22,"phone":11,"phoneExt":11,"email":11},"Haichuan Su",{"facility":65,"status":28,"city":66,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"XiangYa Hospital CentralSouth University","Changsha",{"type":33,"coordinates":68},[69,70],112.97087,28.19874,{"lat":70,"lon":69},[73,75],{"name":74,"role":22,"phone":11,"phoneExt":11,"email":11},"Xuejun Gong",{"name":76,"role":22,"phone":11,"phoneExt":11,"email":11},"Jie Ge",{"facility":78,"status":28,"city":79,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Changzhi People's Hospital","Changzhi",{"type":33,"coordinates":81},[82,83],113.10528,36.18389,{"lat":83,"lon":82},[86],{"name":87,"role":22,"phone":11,"phoneExt":11,"email":11},"Jun Zhao",{"facility":89,"status":28,"city":90,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Fujian Cancer Hospital","Fuzhou",{"type":33,"coordinates":92},[93,94],119.30611,26.06139,{"lat":94,"lon":93},[97],{"name":98,"role":22,"phone":11,"phoneExt":11,"email":11},"Jianwei Yang",{"facility":100,"status":28,"city":90,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"General Hospital of Fuzhou",{"type":33,"coordinates":102},[93,94],{"lat":94,"lon":93},[105],{"name":106,"role":22,"phone":11,"phoneExt":11,"email":11},"Dongliang Li",{"facility":108,"status":28,"city":109,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Guangdong Provincial People's Hospital","Guangzhou",{"type":33,"coordinates":111},[112,113],113.25,23.11667,{"lat":113,"lon":112},[116],{"name":117,"role":22,"phone":11,"phoneExt":11,"email":11},"Dong Ma",{"facility":119,"status":28,"city":120,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine","Hangzhou",{"type":33,"coordinates":122},[123,124],120.16142,30.29365,{"lat":124,"lon":123},[127],{"name":128,"role":22,"phone":11,"phoneExt":11,"email":11},"Hongming Pan",{"facility":130,"status":28,"city":120,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"Zhejiang Cancer Hospital",{"type":33,"coordinates":132},[123,124],{"lat":124,"lon":123},[135],{"name":136,"role":22,"phone":11,"phoneExt":11,"email":11},"Haijun Zhong",{"facility":138,"status":28,"city":139,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Harbin Medical University Cancer Hospital","Harbin",{"type":33,"coordinates":141},[142,143],126.65,45.75,{"lat":143,"lon":142},[146],{"name":147,"role":22,"phone":11,"phoneExt":11,"email":11},"Yanqiao Zhang",{"facility":149,"status":28,"city":150,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Anhui Provincial Cancer Hospital","Hefei",{"type":33,"coordinates":152},[153,154],117.28083,31.86389,{"lat":154,"lon":153},[157],{"name":158,"role":22,"phone":11,"phoneExt":11,"email":11},"Yifu He",{"facility":160,"status":28,"city":161,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Hengshui People's Hospital","Hengshui",{"type":33,"coordinates":163},[164,165],115.68348,37.73908,{"lat":165,"lon":164},[168],{"name":169,"role":22,"phone":11,"phoneExt":11,"email":11},"Daqing Wang",{"facility":171,"status":28,"city":172,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Yunnan Cancer Hospital","Kunming",{"type":33,"coordinates":174},[175,176],102.71833,25.03889,{"lat":176,"lon":175},[179],{"name":180,"role":22,"phone":11,"phoneExt":11,"email":11},"Yunfeng Li",{"facility":182,"status":28,"city":183,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Fudan University Shanghai Cancer Center","Shanghai",{"type":33,"coordinates":185},[186,187],121.45806,31.22222,{"lat":187,"lon":186},[190],{"name":191,"role":22,"phone":11,"phoneExt":11,"email":11},"Zhiyu Chen",{"facility":193,"status":28,"city":183,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"Shanghai General Hospital",{"type":33,"coordinates":195},[186,187],{"lat":187,"lon":186},[198],{"name":199,"role":22,"phone":11,"phoneExt":11,"email":11},"Qi Li",{"facility":201,"status":28,"city":183,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":202,"geoPoint":204,"contacts":205},"The Third Affiliated Hospital of Air Force Medical University",{"type":33,"coordinates":203},[186,187],{"lat":187,"lon":186},[206],{"name":207,"role":22,"phone":11,"phoneExt":11,"email":11},"Qian Zhang",{"facility":209,"status":28,"city":183,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":210,"geoPoint":212,"contacts":213},"Zhongshan Hospital",{"type":33,"coordinates":211},[186,187],{"lat":187,"lon":186},[214,216],{"name":215,"role":22,"phone":11,"phoneExt":11,"email":11},"Houbao Liu",{"name":217,"role":22,"phone":11,"phoneExt":11,"email":11},"Huichuan Sun",{"facility":219,"status":28,"city":220,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Shantou University Medical College Cancer Hospital","Shantou",{"type":33,"coordinates":222},[223,224],116.67876,23.35489,{"lat":224,"lon":223},[227],{"name":228,"role":22,"phone":11,"phoneExt":11,"email":11},"Yi Jiang",{"facility":230,"status":28,"city":231,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Liaoning Cancer Hospital","Shenyang",{"type":33,"coordinates":233},[234,235],123.43278,41.79222,{"lat":235,"lon":234},[238],{"name":239,"role":22,"phone":11,"phoneExt":11,"email":11},"Jingdong Zhang",{"facility":241,"status":28,"city":242,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Shanxi Cancer Hospital","Taiyuan",{"type":33,"coordinates":244},[245,246],112.56028,37.86944,{"lat":246,"lon":245},[249],{"name":250,"role":22,"phone":11,"phoneExt":11,"email":11},"Wenhui Yang",{"facility":252,"status":28,"city":253,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Tianjin Medical University Cancer institute & Hospital","Tianjin",{"type":33,"coordinates":255},[256,257],117.17667,39.14222,{"lat":257,"lon":256},[260],{"name":261,"role":22,"phone":11,"phoneExt":11,"email":11},"Zhanyu Pan",{"facility":263,"status":28,"city":264,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Hubei Cancer Hospital","Wuhan",{"type":33,"coordinates":266},[267,268],114.26667,30.58333,{"lat":268,"lon":267},[271],{"name":272,"role":22,"phone":11,"phoneExt":11,"email":11},"Lei Nie",{"facility":274,"status":28,"city":275,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Affiliated Hospital of Jiangnan University","Wuxi",{"type":33,"coordinates":277},[278,279],120.28857,31.56887,{"lat":279,"lon":278},[282],{"name":283,"role":22,"phone":11,"phoneExt":11,"email":11},"Gaoxiang",{"facility":285,"status":28,"city":286,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi'an",{"type":33,"coordinates":288},[289,290],108.92861,34.25833,{"lat":290,"lon":289},[293],{"name":294,"role":22,"phone":11,"phoneExt":11,"email":11},"Enxiao Li",{"facility":296,"status":28,"city":297,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"The First Affiliated Hospital of Xiamen University","Xiamen",{"type":33,"coordinates":299},[300,301],118.08187,24.47979,{"lat":301,"lon":300},[304],{"name":305,"role":22,"phone":11,"phoneExt":11,"email":11},"Weiwei Tang",{"facility":307,"status":28,"city":308,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Xiangyang Central Hospital","Xiangyang",{"type":33,"coordinates":310},[311,312],112.14479,32.0422,{"lat":312,"lon":311},[315],{"name":316,"role":22,"phone":11,"phoneExt":11,"email":11},"Wei Gong",{"facility":318,"status":28,"city":319,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Yantai Yuhuangding Hospital","Yantai",{"type":33,"coordinates":321},[322,323],121.44081,37.47649,{"lat":323,"lon":322},[326],{"name":327,"role":22,"phone":11,"phoneExt":11,"email":11},"Jian Chen",{"facility":329,"status":28,"city":330,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"Henan Cancer Hospital","Zhengzhou",{"type":33,"coordinates":332},[333,334],113.64861,34.75778,{"lat":334,"lon":333},[337],{"name":338,"role":22,"phone":11,"phoneExt":11,"email":11},"Xiaobing Chen",{"type":340,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100549482","phase-2-a-clinical-study-of-sph5030-tablets-in-the-treatment-of-her2-positivemutated-biliary-tract-or-colorectal-cancer-patients-100549482",false,"NCT06434597","A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive\u002FMutated Biliary Tract OR Colorectal Cancer Patients.","A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive\u002FMutated Biliary Tract OR Colorectal Cancer.","Inclusion Criteria:\n\n1. Metastatic and\u002For unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and\u002For unresectable advanced biliary tract carcinoma\n2. HER2 positive or HER2 gene mutation;\n3. Meet the requirements of previous treatment;\n4. ECOG performance status of 0 or 1；\n5. Expected survival ≥ 3 months;\n6. No serious abnormalities in hematopoietic function, liver or kidney function;\n7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;\n8. Fully informed subjects who voluntarily sign the ICF.\n\nExclusion Criteria:\n\n1. Subjects who have previously received anti-HER2 molecular targeted therapy;\n2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;\n3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;\n\n5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.","ALL","18 Years",{"count":351,"type":352},60,"ESTIMATED","INTERVENTIONAL",[355],"PHASE2","To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive\u002Fmutated biliary tract OR colorectal cancer.",[358],"Biliary Tract or Colorectal Cancer With Her2-positive\u002FMutated","2025-08-15",{"date":361,"type":362},"2025-08-17","ACTUAL",{"date":364,"type":362},"2024-07-17",{"date":366,"type":352},"2026-12-31",{"name":5,"class":6},30]