[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531162":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":210,"collaborators":31,"id":212,"slug":213,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":31,"eligibilityCriteria":218,"healthyVolunteers":214,"sex":219,"minAge":220,"maxAge":31,"enrollmentInfo":221,"targetDuration":31,"studyType":224,"phases":225,"briefSummary":227,"conditions":228,"keywords":31,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"fullName":5,"class":6},"Akeso","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"AK117 (dose 1) in combination with azacitidine","EXPERIMENTAL","Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg\u002Fm2, D1-7, Q4W) subcutaneously",[13,14],"Drug: AK117","Drug: Azacitidine",{"label":16,"type":10,"description":17,"interventionNames":18},"AK117 (dose 2) in combination with azacitidine","Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg\u002Fm2, D1-7, Q4W) subcutaneously",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo in combination with azacitidine","PLACEBO_COMPARATOR","Subjects receive placebo intravenously, in combination with azacitidine (75 mg\u002Fm2, D1-7, Q4W) subcutaneously",[24,14],"Drug: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","AK117","AK117 IV injection",[9,16],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo","Placebo IV injection",[20],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Azacitidine","Azacitidine SC injection",[9,16,20],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Wenting Li, MD","CONTACT","(+86)18116403289","wenting01.li@akesobio.com",[47,61,71,81,91,101,110,120,130,140,150,159,173,183,197],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":31},"UCLA Ronald Reagan Medical Center","RECRUITING","Los Angeles","California","90095","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-118.24368,34.05223,{"lat":59,"lon":58},{"facility":62,"status":49,"city":63,"state":64,"zip":65,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":70,"contacts":31},"Rocky Mountain Cancer Centers","Aurora","Colorado","80012",{"type":56,"coordinates":67},[68,69],-104.83192,39.72943,{"lat":69,"lon":68},{"facility":72,"status":49,"city":73,"state":74,"zip":75,"country":53,"countryCode":54,"cosmosGeoPoint":76,"geoPoint":80,"contacts":31},"Yale Cancer Center","New Haven","Connecticut","06510",{"type":56,"coordinates":77},[78,79],-72.92816,41.30815,{"lat":79,"lon":78},{"facility":82,"status":49,"city":83,"state":84,"zip":85,"country":53,"countryCode":54,"cosmosGeoPoint":86,"geoPoint":90,"contacts":31},"Mid Florida Hematology and Oncology Center","Orange City","Florida","32763",{"type":56,"coordinates":87},[88,89],-81.29867,28.94888,{"lat":89,"lon":88},{"facility":92,"status":49,"city":93,"state":94,"zip":95,"country":53,"countryCode":54,"cosmosGeoPoint":96,"geoPoint":100,"contacts":31},"American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)","Bethesda","Maryland","20817",{"type":56,"coordinates":97},[98,99],-77.10026,38.98067,{"lat":99,"lon":98},{"facility":102,"status":49,"city":103,"state":94,"zip":104,"country":53,"countryCode":54,"cosmosGeoPoint":105,"geoPoint":109,"contacts":31},"Maryland Oncology-Columbia","Columbia","21044",{"type":56,"coordinates":106},[107,108],-76.83942,39.24038,{"lat":108,"lon":107},{"facility":111,"status":49,"city":112,"state":113,"zip":114,"country":53,"countryCode":54,"cosmosGeoPoint":115,"geoPoint":119,"contacts":31},"Washington University School of Medicine in St. Louis","St Louis","Missouri","63110",{"type":56,"coordinates":116},[117,118],-90.19789,38.62727,{"lat":118,"lon":117},{"facility":121,"status":49,"city":122,"state":123,"zip":124,"country":53,"countryCode":54,"cosmosGeoPoint":125,"geoPoint":129,"contacts":31},"Montefiore Einstein Comprehensive Cancer Center","The Bronx","New York","10467",{"type":56,"coordinates":126},[127,128],-73.86641,40.84985,{"lat":128,"lon":127},{"facility":131,"status":49,"city":132,"state":133,"zip":134,"country":53,"countryCode":54,"cosmosGeoPoint":135,"geoPoint":139,"contacts":31},"UNC Lineberger Comprehensive Cancer Center","Chapel Hill","North Carolina","27514",{"type":56,"coordinates":136},[137,138],-79.05584,35.9132,{"lat":138,"lon":137},{"facility":141,"status":49,"city":142,"state":143,"zip":144,"country":53,"countryCode":54,"cosmosGeoPoint":145,"geoPoint":149,"contacts":31},"Gabrail Cancer Center","Canton","Ohio","44718",{"type":56,"coordinates":146},[147,148],-81.37845,40.79895,{"lat":148,"lon":147},{"facility":151,"status":49,"city":152,"state":143,"zip":153,"country":53,"countryCode":54,"cosmosGeoPoint":154,"geoPoint":158,"contacts":31},"Ohio State University","Columbus","43210",{"type":56,"coordinates":155},[156,157],-82.99879,39.96118,{"lat":157,"lon":156},{"facility":160,"status":49,"city":161,"state":162,"zip":163,"country":53,"countryCode":54,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Oncology Associates of Oregon","Eugene","Oregon","97401",{"type":56,"coordinates":165},[166,167],-123.08675,44.05207,{"lat":167,"lon":166},[170],{"name":171,"role":43,"phone":31,"phoneExt":31,"email":172},"Luke Fletcher","luke.fletcher@usoncology.com",{"facility":174,"status":49,"city":175,"state":176,"zip":177,"country":53,"countryCode":54,"cosmosGeoPoint":178,"geoPoint":182,"contacts":31},"MUSC Hollings Cancer Center","Charleston","South Carolina","29425",{"type":56,"coordinates":179},[180,181],-79.93275,32.77632,{"lat":181,"lon":180},{"facility":184,"status":49,"city":185,"state":186,"zip":187,"country":53,"countryCode":54,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"UT Southwestern Medical Center","Dallas","Texas","75390-9065",{"type":56,"coordinates":189},[190,191],-96.80667,32.78306,{"lat":191,"lon":190},[194],{"name":195,"role":43,"phone":31,"phoneExt":31,"email":196},"Yazan Madanat","yazan.madanat@utsouthwestern.edu",{"facility":198,"status":49,"city":199,"state":31,"zip":31,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college","Tianjin","China","CN",{"type":56,"coordinates":203},[204,205],117.17667,39.14222,{"lat":205,"lon":204},[208],{"name":209,"role":43,"phone":31,"phoneExt":31,"email":31},"Zhijian Xiao",{"type":211,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100531162","phase-2-a-study-of-ak117-in-combination-with-azacitidine-in-patients-with-myelodysplastic-syndromes-100531162",false,"NCT06196203","A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study of AK117\u002FPlacebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes","Inclusion Criteria:\n\n* Age ≥ 18 years old at the time of enrolment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.\n* Expected life expectancy ≥ 3 months.\n* Newly diagnosed HR-MDS, according to the 2016 World Health Organization (WHO) classification with the presence of \\\u003C 20% blasts in bone marrow or peripheral blood; Overall IPSS-R score ≥ 3.5.\n* Ability to undergo the study-required bone marrow sample collection procedures.\n* Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity).\n* Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 180 days after the last dose of the study treatment.\n* Unsterilized male patients having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until 180 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplastic\u002Fmyeloproliferative neoplasms (MDS\u002FMPN).\n* Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.\n* Concurrently participating in another interventional clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n* Patients who previously diagnosed with another malignancy and have any evidence of residual disease.\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies.\n* Patients with any psychiatric or social factor which the investigator deems may interfere with the patient's ability to comply with the requirements of the study.\n* Patients with current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n* Patients with known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders.\n* Patients who are breastfeeding or plans to breastfeed during the study.\n* Other conditions where the investigator considers the patient inappropriate for enrollment.","ALL","18 Years",{"count":222,"type":223},90,"ESTIMATED","INTERVENTIONAL",[226],"PHASE2","This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).",[229],"Higher-risk Myelodysplastic Syndromes","2025-02-09",{"date":232,"type":233},"2025-02-11","ACTUAL",{"date":235,"type":233},"2024-02-07",{"date":237,"type":223},"2026-06",{"name":5,"class":6},15]