[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645753":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":48,"locations":54,"responsibleParty":235,"collaborators":35,"id":237,"slug":238,"hasResults":239,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":35,"eligibilityCriteria":243,"healthyVolunteers":239,"sex":244,"minAge":245,"maxAge":246,"enrollmentInfo":247,"targetDuration":35,"studyType":250,"phases":251,"briefSummary":253,"conditions":254,"keywords":35,"overallStatus":256,"whyStopped":35,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},{"fullName":5,"class":6},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1. SKB500+Tislelizumab","EXPERIMENTAL","Participants will receive Tislelizumab followed by SKB500",[13,14],"Drug: SKB500","Drug: Tislelizumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2. SKB500+Tislelizumab+5-FU","Participants will receive Tislelizumab followed by SKB500, 5-FU",[13,14,19],"Drug: 5 - FU",{"label":21,"type":10,"description":22,"interventionNames":23},"Cohort 3. SKB500+Tislelizumab+ Cisplatin","Participants will receive Tislelizumab followed by SKB500, Cisplatin",[13,14,24],"Drug: Cisplatin",{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort 4. SKB500+Tislelizumab+ Cisplatin+5-FU","Participants will receive Tislelizumab followed by SKB500, Cisplatin, 5-FU",[13,14,24,19],[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","SKB500","SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.",[9,16,21,26],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Tislelizumab","Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .",[9,16,21,26],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Cisplatin","Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.",[21,26],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"5 - FU","5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.",[16,26],[49],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},"Qing Yan","CONTACT","028-67255480","qingyan@kelun.com",[55,66,74,79,84,92,100,108,121,129,137,145,153,158,166,174,182,190,198,206,214,222,230],{"facility":56,"status":35,"city":57,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":35},"Jilin Cancer Hospital","Changchun","China","CN",{"type":61,"coordinates":62},"Point",[63,64],125.32278,43.88,{"lat":64,"lon":63},{"facility":67,"status":35,"city":68,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":69,"geoPoint":73,"contacts":35},"Chengdu Fifth People's Hospital","Chengdu",{"type":61,"coordinates":70},[71,72],104.06667,30.66667,{"lat":72,"lon":71},{"facility":75,"status":35,"city":68,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":76,"geoPoint":78,"contacts":35},"Sichuan Cancer Hospital & Institute",{"type":61,"coordinates":77},[71,72],{"lat":72,"lon":71},{"facility":80,"status":35,"city":68,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":81,"geoPoint":83,"contacts":35},"West China Hospital, Sichuan University",{"type":61,"coordinates":82},[71,72],{"lat":72,"lon":71},{"facility":85,"status":35,"city":86,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":87,"geoPoint":91,"contacts":35},"Chongqing University Three Gorges Hospital","Chongqing",{"type":61,"coordinates":88},[89,90],106.55771,29.56026,{"lat":90,"lon":89},{"facility":93,"status":35,"city":94,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":95,"geoPoint":99,"contacts":35},"Fujian Cancer Hospital","Fuzhou",{"type":61,"coordinates":96},[97,98],119.30611,26.06139,{"lat":98,"lon":97},{"facility":101,"status":35,"city":102,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":103,"geoPoint":107,"contacts":35},"Harbin Medical University Cancer 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Technology","Luoyang",{"type":61,"coordinates":133},[134,135],112.43684,34.67345,{"lat":135,"lon":134},{"facility":138,"status":35,"city":139,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":140,"geoPoint":144,"contacts":35},"The Second Affiliated Hospital of Nanchang University","Nanchang",{"type":61,"coordinates":141},[142,143],115.85306,28.68396,{"lat":143,"lon":142},{"facility":146,"status":35,"city":147,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":148,"geoPoint":152,"contacts":35},"Jiangsu Cancer Hospital","Nanjing",{"type":61,"coordinates":149},[150,151],118.77778,32.06167,{"lat":151,"lon":150},{"facility":154,"status":35,"city":147,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":155,"geoPoint":157,"contacts":35},"Jiangsu Province 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University","Shijiazhuang",{"type":61,"coordinates":178},[179,180],114.47861,38.04139,{"lat":180,"lon":179},{"facility":183,"status":35,"city":184,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":185,"geoPoint":189,"contacts":35},"Shiyan Renmin Hospital","Shiyan",{"type":61,"coordinates":186},[187,188],110.77806,32.6475,{"lat":188,"lon":187},{"facility":191,"status":35,"city":192,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":193,"geoPoint":197,"contacts":35},"Shanxi Cancer Hospital","Taiyuan",{"type":61,"coordinates":194},[195,196],112.56028,37.86944,{"lat":196,"lon":195},{"facility":199,"status":35,"city":200,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":201,"geoPoint":205,"contacts":35},"Tianjin Medical University Cancer Institute & 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Hospital","Zhengzhou",{"type":61,"coordinates":226},[227,228],113.64861,34.75778,{"lat":228,"lon":227},{"facility":231,"status":35,"city":224,"state":35,"zip":35,"country":58,"countryCode":59,"cosmosGeoPoint":232,"geoPoint":234,"contacts":35},"The First Affiliated Hospital of Zhengzhou University",{"type":61,"coordinates":233},[227,228],{"lat":228,"lon":227},{"type":236,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100645753","phase-2-skb500-combinations-in-patients-with-esophageal-squamous-cell-carcinoma-100645753",false,"NCT07700667","SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma","A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years\n2. Histologically or cytologically confirmed unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), who are ineligible for curative-intent therapies:\n\n   * Safety run-in phase (Cohort 1, 2 and 3): received no more than 1 prior line of systemic therapy for locally advanced or metastatic ESCC.\n   * Safety run-in phase (Cohort 4), randomized enrollment phase and cohort expansion phase: no prior systemic therapy for locally advanced or metastatic ESCC.\n3. Participants are required to provide tumor tissue samples for biomarker analysis.\n4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Histology or cytology confirms the presence of concurrent adenocarcinoma components.\n2. Leptomeningeal, brainstem, spinal, spinal cord compression, or active CNS metastases.\n3. Risk of esophagotracheal\u002Fesophagopleural fistula, or symptomatic invasion\u002Fcompression of vital organs\u002Fmajor blood vessels.\n4. Active autoimmune disease requiring systemic therapy within past 2 years.\n5. Weight loss ≥10% within 4 weeks prior to the first dose, or Nutritional Risk Index (NRI) \\\u003C 83.5.\n6. Severe infection within 4 weeks or active infection requiring systemic treatment within 2 weeks pre-dose.\n7. Uncontrolled comorbidities (e.g., decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Grade ≥2 peripheral neuropathy).\n8. Cardiovascular\u002Fcerebrovascular events within 6 months pre-dose (e.g., Myocardial Infarction, unstable angina, acute\u002Fpersistent ischemia, Grade 3\u002F4 Heart Failure, symptomatic\u002Funcontrolled arrhythmia, Cerebrovascular Accident, Transient Ischemic Attack).\n9. Uncontrolled hypertension, diabetes, or recurrent pleural\u002Fpericardial\u002Fabdominal effusion requiring drainage.\n10. History of interstitial lung disease (ILD) or noninfectious pneumonitis that require steroid treatment, or currently has ILD\u002Fnoninfectious pneumonitis.\n11. Unresolved to grade ≤ 1 of prior anti-cancer treatment toxicities criteria per CTCAE v6.0.\n12. Previously received B7-H3-targeted agents, including antibody, antibodydrug conjugate (ADC), and other agents.\n13. Previously received treatment with an ADC that consists of a topoisomerase l inhibitor.\n14. Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":248,"type":249},120,"ESTIMATED","INTERVENTIONAL",[252],"PHASE2","The purpose of this study is to evaluate the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with Esophageal Squamous Cell Carcinoma. The study is divided into three parts: the safety run-in phase, randomized enrollment phase and cohort expansion phase.",[255],"Esophageal Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-07-08",{"date":259,"type":260},"2026-07-14","ACTUAL",{"date":262,"type":249},"2026-07-30",{"date":264,"type":249},"2029-12-31",{"name":5,"class":6},23]