[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531162":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":208,"collaborators":31,"id":210,"slug":31,"hasResults":211,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":31,"eligibilityCriteria":215,"healthyVolunteers":211,"sex":216,"minAge":217,"maxAge":31,"enrollmentInfo":218,"targetDuration":31,"studyType":221,"phases":222,"briefSummary":224,"conditions":225,"keywords":31,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"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",[47,60,70,80,90,100,109,119,129,139,149,158,172,182,196],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":31},"UCLA Ronald Reagan Medical Center","RECRUITING","Los Angeles","California","90095","United States",{"type":55,"coordinates":56},"Point",[57,58],-118.24368,34.05223,{"lat":58,"lon":57},{"facility":61,"status":49,"city":62,"state":63,"zip":64,"country":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":31},"Rocky Mountain Cancer Centers","Aurora","Colorado","80012",{"type":55,"coordinates":66},[67,68],-104.83192,39.72943,{"lat":68,"lon":67},{"facility":71,"status":49,"city":72,"state":73,"zip":74,"country":53,"cosmosGeoPoint":75,"geoPoint":79,"contacts":31},"Yale Cancer Center","New Haven","Connecticut","06510",{"type":55,"coordinates":76},[77,78],-72.92816,41.30815,{"lat":78,"lon":77},{"facility":81,"status":49,"city":82,"state":83,"zip":84,"country":53,"cosmosGeoPoint":85,"geoPoint":89,"contacts":31},"Mid Florida Hematology and Oncology Center","Orange City","Florida","32763",{"type":55,"coordinates":86},[87,88],-81.29867,28.94888,{"lat":88,"lon":87},{"facility":91,"status":49,"city":92,"state":93,"zip":94,"country":53,"cosmosGeoPoint":95,"geoPoint":99,"contacts":31},"American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)","Bethesda","Maryland","20817",{"type":55,"coordinates":96},[97,98],-77.10026,38.98067,{"lat":98,"lon":97},{"facility":101,"status":49,"city":102,"state":93,"zip":103,"country":53,"cosmosGeoPoint":104,"geoPoint":108,"contacts":31},"Maryland Oncology-Columbia","Columbia","21044",{"type":55,"coordinates":105},[106,107],-76.83942,39.24038,{"lat":107,"lon":106},{"facility":110,"status":49,"city":111,"state":112,"zip":113,"country":53,"cosmosGeoPoint":114,"geoPoint":118,"contacts":31},"Washington University School of Medicine in St. Louis","St Louis","Missouri","63110",{"type":55,"coordinates":115},[116,117],-90.19789,38.62727,{"lat":117,"lon":116},{"facility":120,"status":49,"city":121,"state":122,"zip":123,"country":53,"cosmosGeoPoint":124,"geoPoint":128,"contacts":31},"Montefiore Einstein Comprehensive Cancer Center","The Bronx","New York","10467",{"type":55,"coordinates":125},[126,127],-73.86641,40.84985,{"lat":127,"lon":126},{"facility":130,"status":49,"city":131,"state":132,"zip":133,"country":53,"cosmosGeoPoint":134,"geoPoint":138,"contacts":31},"UNC Lineberger Comprehensive Cancer Center","Chapel Hill","North Carolina","27514",{"type":55,"coordinates":135},[136,137],-79.05584,35.9132,{"lat":137,"lon":136},{"facility":140,"status":49,"city":141,"state":142,"zip":143,"country":53,"cosmosGeoPoint":144,"geoPoint":148,"contacts":31},"Gabrail Cancer Center","Canton","Ohio","44718",{"type":55,"coordinates":145},[146,147],-81.37845,40.79895,{"lat":147,"lon":146},{"facility":150,"status":49,"city":151,"state":142,"zip":152,"country":53,"cosmosGeoPoint":153,"geoPoint":157,"contacts":31},"Ohio State University","Columbus","43210",{"type":55,"coordinates":154},[155,156],-82.99879,39.96118,{"lat":156,"lon":155},{"facility":159,"status":49,"city":160,"state":161,"zip":162,"country":53,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Oncology Associates of Oregon","Eugene","Oregon","97401",{"type":55,"coordinates":164},[165,166],-123.08675,44.05207,{"lat":166,"lon":165},[169],{"name":170,"role":43,"phone":31,"phoneExt":31,"email":171},"Luke Fletcher","luke.fletcher@usoncology.com",{"facility":173,"status":49,"city":174,"state":175,"zip":176,"country":53,"cosmosGeoPoint":177,"geoPoint":181,"contacts":31},"MUSC Hollings Cancer Center","Charleston","South Carolina","29425",{"type":55,"coordinates":178},[179,180],-79.93275,32.77632,{"lat":180,"lon":179},{"facility":183,"status":49,"city":184,"state":185,"zip":186,"country":53,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"UT Southwestern Medical Center","Dallas","Texas","75390-9065",{"type":55,"coordinates":188},[189,190],-96.80667,32.78306,{"lat":190,"lon":189},[193],{"name":194,"role":43,"phone":31,"phoneExt":31,"email":195},"Yazan Madanat","yazan.madanat@utsouthwestern.edu",{"facility":197,"status":49,"city":198,"state":31,"zip":31,"country":199,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college","Tianjin","China",{"type":55,"coordinates":201},[202,203],117.17667,39.14222,{"lat":203,"lon":202},[206],{"name":207,"role":43,"phone":31,"phoneExt":31,"email":31},"Zhijian Xiao",{"type":209,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","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":219,"type":220},90,"ESTIMATED","INTERVENTIONAL",[223],"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).",[226],"Higher-risk Myelodysplastic Syndromes","2025-02-09",{"date":229,"type":230},"2025-02-11","ACTUAL",{"date":232,"type":230},"2024-02-07",{"date":234,"type":220},"2026-06",{"name":5,"class":6},15]