[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566539":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":25,"locations":31,"responsibleParty":292,"collaborators":11,"id":294,"slug":295,"hasResults":296,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":11,"eligibilityCriteria":300,"healthyVolunteers":296,"sex":301,"minAge":302,"maxAge":11,"enrollmentInfo":303,"targetDuration":11,"studyType":306,"phases":307,"briefSummary":309,"conditions":310,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},{"fullName":5,"class":6},"Beijing InnoCare Pharma Tech Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ICP-248 in combination with azacitidine","EXPERIMENTAL",null,[13,14],"Drug: ICP-248","Drug: Azacitidine",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","ICP-248","Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"Azacitidine","Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol，once daily on days 1-7 of each 28-day cycle.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Alexia Lu","CONTACT","010-66609745","CO_HGRAC@innocarepharma.com",[32,51,65,82,97,113,128,142,156,166,181,195,210,225,239,248,262,277],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Yale University, Yale Cancer Center","RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-72.92816,41.30815,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":11,"email":50},"Farah Fasihuddin","(203) 494-4610","farah.fasihuddin@yale.edu",{"facility":52,"status":34,"city":53,"state":53,"zip":54,"country":38,"countryCode":39,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"NYU Langone Health","New York","10016",{"type":41,"coordinates":56},[57,58],-74.00597,40.71427,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":63,"phoneExt":11,"email":64},"Antoine Mesidor","212-263-4403","antoine.mesidor@nyulangone.org",{"facility":66,"status":34,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"St Vincent's Hospital","Sydney","New South Wales","2010","Australia","AU",{"type":41,"coordinates":73},[74,75],151.20732,-33.86785,{"lat":75,"lon":74},[78],{"name":79,"role":28,"phone":80,"phoneExt":11,"email":81},"Keith Fay","0478267680","keith.fay@svha.org.au",{"facility":83,"status":34,"city":84,"state":85,"zip":86,"country":70,"countryCode":71,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Royal Perth Hospital","Perth","Western Australia","6000",{"type":41,"coordinates":88},[89,90],115.8614,-31.95224,{"lat":90,"lon":89},[93],{"name":94,"role":28,"phone":95,"phoneExt":11,"email":96},"Hun Chuah","0892242405","HunSheng.Chuah@health.wa.gov.au",{"facility":98,"status":34,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Anhui Provincial Hospita","Hefei","Anhui","230001","China","CN",{"type":41,"coordinates":105},[106,107],117.28083,31.86389,{"lat":107,"lon":106},[110],{"name":111,"role":28,"phone":11,"phoneExt":11,"email":112},"Xiaoyu Zhu","xiaoyuz@ustc.edu.cn",{"facility":114,"status":34,"city":115,"state":116,"zip":117,"country":102,"countryCode":103,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Peking University People's Hospital","Beijing","Beijing Municipality","100044",{"type":41,"coordinates":119},[120,121],116.39723,39.9075,{"lat":121,"lon":120},[124],{"name":125,"role":28,"phone":126,"phoneExt":11,"email":127},"Qian Jiang","010-88326850","jiangqian@medmail.com.cn",{"facility":129,"status":34,"city":130,"state":131,"zip":132,"country":102,"countryCode":103,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality","400042",{"type":41,"coordinates":134},[135,136],106.55771,29.56026,{"lat":136,"lon":135},[139],{"name":140,"role":28,"phone":11,"phoneExt":11,"email":141},"Li Wang","liwangls@yahoo.com",{"facility":143,"status":34,"city":144,"state":145,"zip":146,"country":102,"countryCode":103,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Guangdong Provincial People's Hospital","Guangzhou","Guangdong","510030",{"type":41,"coordinates":148},[149,150],113.25,23.11667,{"lat":150,"lon":149},[153],{"name":154,"role":28,"phone":11,"phoneExt":11,"email":155},"Jianyu Weng","wengjianyu1969@163.com",{"facility":157,"status":34,"city":144,"state":145,"zip":158,"country":102,"countryCode":103,"cosmosGeoPoint":159,"geoPoint":161,"contacts":162},"Nanfang Hospital Southern Medical University","510515",{"type":41,"coordinates":160},[149,150],{"lat":150,"lon":149},[163],{"name":164,"role":28,"phone":11,"phoneExt":11,"email":165},"Yunyun Pan","huiyun1227@163.com",{"facility":167,"status":34,"city":168,"state":169,"zip":170,"country":102,"countryCode":103,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Henan Cancer Hospital","Zhengzhou","Henan","450000",{"type":41,"coordinates":172},[173,174],113.64861,34.75778,{"lat":174,"lon":173},[177],{"name":178,"role":28,"phone":179,"phoneExt":11,"email":180},"Xudong Wei","0371-65587038","weixudong63@126.com",{"facility":182,"status":34,"city":183,"state":184,"zip":185,"country":102,"countryCode":103,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","Hubei","430000",{"type":41,"coordinates":187},[188,189],114.26667,30.58333,{"lat":189,"lon":188},[192],{"name":193,"role":28,"phone":11,"phoneExt":11,"email":194},"Zhichao Chen","chenzhichao@hust.edu.cn",{"facility":196,"status":34,"city":197,"state":198,"zip":199,"country":102,"countryCode":103,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"The First Affiliated Hospital of Soochow University","Suzhou","Jiangsu","215006",{"type":41,"coordinates":201},[202,203],120.59538,31.30408,{"lat":203,"lon":202},[206],{"name":207,"role":28,"phone":208,"phoneExt":11,"email":209},"Suning Chen","0512-67781137","chensuning@suda.edu.cn",{"facility":211,"status":34,"city":212,"state":213,"zip":214,"country":102,"countryCode":103,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330006",{"type":41,"coordinates":216},[217,218],115.85306,28.68396,{"lat":218,"lon":217},[221],{"name":222,"role":28,"phone":223,"phoneExt":11,"email":224},"Fei Li","0791-88692743","lifeigcp2022@163.com",{"facility":226,"status":34,"city":227,"state":228,"zip":229,"country":102,"countryCode":103,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"The First Hospital of Jilin University","Changchun","Jilin","130000",{"type":41,"coordinates":231},[232,233],125.32278,43.88,{"lat":233,"lon":232},[236],{"name":237,"role":28,"phone":11,"phoneExt":11,"email":238},"Sujun Gao","sujung1963@163.com",{"facility":240,"status":34,"city":241,"state":242,"zip":243,"country":102,"countryCode":103,"cosmosGeoPoint":11,"geoPoint":11,"contacts":244},"Shengjing Hospital of China Medical University","Shengyang","Liaoning","110004",[245],{"name":246,"role":28,"phone":11,"phoneExt":11,"email":247},"Aijun Liao","liaoaijun@sina.com",{"facility":249,"status":34,"city":250,"state":251,"zip":252,"country":102,"countryCode":103,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Sichuan Provincial People's Hospital","Chengdu","Sichuan","610072",{"type":41,"coordinates":254},[255,256],104.06667,30.66667,{"lat":256,"lon":255},[259],{"name":260,"role":28,"phone":11,"phoneExt":11,"email":261},"xiaobing Huang","huangxiaobing@med.uestc.edu.cn",{"facility":263,"status":34,"city":264,"state":265,"zip":266,"country":102,"countryCode":103,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Tianjin People's Hospital","Tianjin","Tianjin Municipality","300192",{"type":41,"coordinates":268},[269,270],117.17667,39.14222,{"lat":270,"lon":269},[273],{"name":274,"role":28,"phone":275,"phoneExt":11,"email":276},"Xingli Zhao","022-27557959","insectzhao@163.com",{"facility":278,"status":34,"city":279,"state":280,"zip":281,"country":102,"countryCode":103,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310012",{"type":41,"coordinates":283},[284,285],120.16142,30.29365,{"lat":285,"lon":284},[288],{"name":289,"role":28,"phone":290,"phoneExt":11,"email":291},"Jie Jin","0571-87236898","jiej0503@163.com",{"type":293,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100566539","phase-1-icp-248-in-combination-with-azacitidine-for-the-treatment-in-patients-with-myeloid-malignancies-100566539",false,"NCT06656494","ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies","A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.","Inclusion Criteria:\n\nEligible subjects must meet all of the following criteria:\n\n1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \\[APL\\]) or MDS per 2016 World Health Organization (WHO) criteria.\n2. For AML (except for APL) cohort:\n\n   1. Previously treated relapsed\u002Frefractory AML subjects\n   2. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and \\\u003C60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy\n3. For MDS cohort: Adult TN MDS and R\u002FR MDS: revised International Prognostic Scoring System (IPSS-R) score \\> 3 and bone marrow blasts ≥ 5%.\n4. Subject must have a projected life expectancy of at least 12 weeks.\n5. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.\n6. Subject must have adequate liver function\n\nExclusion Criteria:\n\n1. R\u002FR AML or R\u002FR MDS with no response or intolerance to post azacitidine or BCL-2i.\n2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .\n3. Subject has known central nervous system (CNS) leukemia.\n4. Suggest patients with active hepatitis B or C virus infection\n5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.\n6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.","ALL","18 Years",{"count":304,"type":305},266,"ESTIMATED","INTERVENTIONAL",[308],"PHASE1","Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.",[311,312],"Acute Myelogenous Leukemia","Myelodysplastic Syndromes (MDS)","2026-04-08",{"date":315,"type":316},"2026-04-13","ACTUAL",{"date":318,"type":316},"2024-12-18",{"date":320,"type":305},"2028-01",{"name":5,"class":6},18]