[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636344":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":267,"collaborators":11,"id":269,"slug":270,"hasResults":271,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":11,"eligibilityCriteria":275,"healthyVolunteers":271,"sex":276,"minAge":277,"maxAge":278,"enrollmentInfo":279,"targetDuration":11,"studyType":282,"phases":283,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":290,"whyStopped":11,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":300},{"fullName":5,"class":6},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Gastric Cancer\u002FGastroesophageal Junction Adenocarcinoma (GC\u002FGEJ)","EXPERIMENTAL",null,[13],"Drug: SKB571 for injection",{"label":15,"type":10,"description":11,"interventionNames":16},"Oesophageal Squamous Cell Carcinoma (ESCC)",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Colorectal Adenocarcinoma (CRC)",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Hepatocellular Carcinoma (HCC) or Bile Duct Cancer (BTC) or other types of gastrointestinal tumors",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","SKB571 for injection","Intravenous(IV) infusion(Q3W)",[18,9,21,15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Xin Li, MD","CONTACT","86-13311373861","lixin@kelun.com",[36,49,59,68,78,84,94,104,114,124,133,139,149,159,165,175,181,191,201,211,221,227,237,247,257],{"facility":37,"status":11,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":11},"Chongqing University Three Gorges Hospital","Chongqing","Chongqing Municipality","404000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],106.55771,29.56026,{"lat":47,"lon":46},{"facility":50,"status":11,"city":51,"state":52,"zip":53,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":58,"contacts":11},"Fujian Cancer Hospital","Fuzhou","Fujian","350014",{"type":44,"coordinates":55},[56,57],119.30611,26.06139,{"lat":57,"lon":56},{"facility":60,"status":11,"city":61,"state":52,"zip":62,"country":41,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":67,"contacts":11},"The First Affiliated Hospital of Xiamen University","Xiamen","361003",{"type":44,"coordinates":64},[65,66],118.08187,24.47979,{"lat":66,"lon":65},{"facility":69,"status":11,"city":70,"state":71,"zip":72,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":11},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":44,"coordinates":74},[75,76],113.25,23.11667,{"lat":76,"lon":75},{"facility":79,"status":11,"city":70,"state":71,"zip":80,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":83,"contacts":11},"The Sixth Affiliated Hospital, Sun Yat-sen University","510655",{"type":44,"coordinates":82},[75,76],{"lat":76,"lon":75},{"facility":85,"status":11,"city":86,"state":87,"zip":88,"country":41,"countryCode":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":11},"The People's Hospital of Guangxi Zhuang Autonomous Region","Nanning","Guangxi","530021",{"type":44,"coordinates":90},[91,92],108.31667,22.81667,{"lat":92,"lon":91},{"facility":95,"status":11,"city":96,"state":97,"zip":98,"country":41,"countryCode":42,"cosmosGeoPoint":99,"geoPoint":103,"contacts":11},"The Fourth Hospital of Hebei Medical University","Shijiazhuang","Hebei","050011",{"type":44,"coordinates":100},[101,102],114.47861,38.04139,{"lat":102,"lon":101},{"facility":105,"status":11,"city":106,"state":107,"zip":108,"country":41,"countryCode":42,"cosmosGeoPoint":109,"geoPoint":113,"contacts":11},"Tumor Hospital of Harbin Medical University","Harbin","Heilongjiang","150081",{"type":44,"coordinates":110},[111,112],126.65,45.75,{"lat":112,"lon":111},{"facility":115,"status":11,"city":116,"state":117,"zip":118,"country":41,"countryCode":42,"cosmosGeoPoint":119,"geoPoint":123,"contacts":11},"The First Affiliated Hospital of Henan University of Science and Technology","Luoyang","Henan","471003",{"type":44,"coordinates":120},[121,122],112.43684,34.67345,{"lat":122,"lon":121},{"facility":125,"status":11,"city":126,"state":117,"zip":127,"country":41,"countryCode":42,"cosmosGeoPoint":128,"geoPoint":132,"contacts":11},"Henan Cancer Hospital","Zhengzhou","450008",{"type":44,"coordinates":129},[130,131],113.64861,34.75778,{"lat":131,"lon":130},{"facility":134,"status":11,"city":126,"state":117,"zip":135,"country":41,"countryCode":42,"cosmosGeoPoint":136,"geoPoint":138,"contacts":11},"The First Affiliated Hospital of Zhengzhou University","450052",{"type":44,"coordinates":137},[130,131],{"lat":131,"lon":130},{"facility":140,"status":11,"city":141,"state":142,"zip":143,"country":41,"countryCode":42,"cosmosGeoPoint":144,"geoPoint":148,"contacts":11},"Hunan Cancer Hospital","Changsha","Hunan","410013",{"type":44,"coordinates":145},[146,147],112.97087,28.19874,{"lat":147,"lon":146},{"facility":150,"status":11,"city":151,"state":152,"zip":153,"country":41,"countryCode":42,"cosmosGeoPoint":154,"geoPoint":158,"contacts":11},"Jiangsu Cancer Hospital","Nanjing","Jiangsu","210009",{"type":44,"coordinates":155},[156,157],118.77778,32.06167,{"lat":157,"lon":156},{"facility":160,"status":11,"city":151,"state":152,"zip":161,"country":41,"countryCode":42,"cosmosGeoPoint":162,"geoPoint":164,"contacts":11},"Jiangsu Province Hospital","210029",{"type":44,"coordinates":163},[156,157],{"lat":157,"lon":156},{"facility":166,"status":11,"city":167,"state":168,"zip":169,"country":41,"countryCode":42,"cosmosGeoPoint":170,"geoPoint":174,"contacts":11},"Jiangxi Cancer Hospital","Nanchang","Jiangxi","3300029",{"type":44,"coordinates":171},[172,173],115.85306,28.68396,{"lat":173,"lon":172},{"facility":176,"status":11,"city":167,"state":168,"zip":177,"country":41,"countryCode":42,"cosmosGeoPoint":178,"geoPoint":180,"contacts":11},"The Second Affiliated Hospital of Nanchang University","330006",{"type":44,"coordinates":179},[172,173],{"lat":173,"lon":172},{"facility":182,"status":11,"city":183,"state":184,"zip":185,"country":41,"countryCode":42,"cosmosGeoPoint":186,"geoPoint":190,"contacts":11},"The First Hospital of Jilin University","Changchun","Jilin","130021",{"type":44,"coordinates":187},[188,189],125.32278,43.88,{"lat":189,"lon":188},{"facility":192,"status":11,"city":193,"state":194,"zip":195,"country":41,"countryCode":42,"cosmosGeoPoint":196,"geoPoint":200,"contacts":11},"The First Hospital of China Medical University","Shenyang","Liaoning","110001",{"type":44,"coordinates":197},[198,199],123.43278,41.79222,{"lat":199,"lon":198},{"facility":202,"status":11,"city":203,"state":204,"zip":205,"country":41,"countryCode":42,"cosmosGeoPoint":206,"geoPoint":210,"contacts":11},"The Second Affiliated Hospital of Xi'an Jiaotong University","Xi'an","Shaanxi","710004",{"type":44,"coordinates":207},[208,209],108.92861,34.25833,{"lat":209,"lon":208},{"facility":212,"status":11,"city":213,"state":214,"zip":215,"country":41,"countryCode":42,"cosmosGeoPoint":216,"geoPoint":220,"contacts":11},"Shandong Provincial Hospital","Jinan","Shandong","250021",{"type":44,"coordinates":217},[218,219],116.99722,36.66833,{"lat":219,"lon":218},{"facility":222,"status":11,"city":213,"state":214,"zip":223,"country":41,"countryCode":42,"cosmosGeoPoint":224,"geoPoint":226,"contacts":11},"Cancer Hospital of Shandong First Medical University","250117",{"type":44,"coordinates":225},[218,219],{"lat":219,"lon":218},{"facility":228,"status":11,"city":229,"state":230,"zip":231,"country":41,"countryCode":42,"cosmosGeoPoint":232,"geoPoint":236,"contacts":11},"Renji Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200127",{"type":44,"coordinates":233},[234,235],121.45806,31.22222,{"lat":235,"lon":234},{"facility":238,"status":11,"city":239,"state":240,"zip":241,"country":41,"countryCode":42,"cosmosGeoPoint":242,"geoPoint":246,"contacts":11},"Shanxi Provincial Cancer Hospital","Taiyuan","Shanxi","030013",{"type":44,"coordinates":243},[244,245],112.56028,37.86944,{"lat":245,"lon":244},{"facility":248,"status":11,"city":249,"state":250,"zip":251,"country":41,"countryCode":42,"cosmosGeoPoint":252,"geoPoint":256,"contacts":11},"Sichuan Cancer Hospital","Chengdu","Sichuan","610041",{"type":44,"coordinates":253},[254,255],104.06667,30.66667,{"lat":255,"lon":254},{"facility":258,"status":11,"city":259,"state":260,"zip":261,"country":41,"countryCode":42,"cosmosGeoPoint":262,"geoPoint":266,"contacts":11},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality","300060",{"type":44,"coordinates":263},[264,265],117.17667,39.14222,{"lat":265,"lon":264},{"type":268,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100636344","phase-2-a-study-of-skb571-in-participants-with-gastrointestinal-tumors-100636344",false,"NCT07564466","A Study of SKB571 in Participants With Gastrointestinal Tumors","A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).\n2. Participants must have histologically or cytologically confirmed gastrointestinal tumors.\n3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy ≥ 12 weeks as assessed by the investigator.\n6. Adequate organ and bone marrow function.\n7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.\n8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Participants with other malignant tumors within 3 years before the first dose of study treatment.\n2. History or current metastases to central nervous system.\n3. Current uncontrolled concomitant diseases\n4. Clinically severe lung damage due to complications of lung disorder\n5. Participants with a history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis\n6. A history of severe skin diseases\n7. Unresolved toxicity from prior anti-tumor therapy\n8. Serious infection within 4 weeks before the first dose of study treatment\n9. Known active pulmonary tuberculosis.\n10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.\n11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.\n12. Pregnant or breastfeeding women.\n13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":280,"type":281},120,"ESTIMATED","INTERVENTIONAL",[284],"PHASE2","This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.",[287],"Gastrointestinal Tumors",[289],"Gastrointestinal tumors","NOT_YET_RECRUITING","2026-05-06",{"date":293,"type":294},"2026-05-11","ACTUAL",{"date":296,"type":281},"2026-06-30",{"date":298,"type":281},"2028-06-30",{"name":5,"class":6},25]