[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06196203":3,"trial-entities:NCT06196203":248,"trial-summary:NCT06196203":252},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":44,"secondary_outcomes":49,"sex":80,"minimum_age":81,"maximum_age":15,"healthy_volunteers":82,"eligibility_criteria":83,"std_ages":106,"locations":109,"central_contacts":240,"overall_officials":245,"references":246,"see_also_links":247},"NCT06196203","AK117-205","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","RECRUITING","2026-06","2025-02","2025-02-11","2024-02-07","Akeso","INDUSTRY",null,"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).",[18],"Higher-risk Myelodysplastic Syndromes",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE2",{"count":25,"type":26},90,"ESTIMATED",[28,35,40],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","AK117","AK117 IV injection",[33,34],"AK117 (dose 1) in combination with azacitidine","AK117 (dose 2) in combination with azacitidine",{"type":29,"name":36,"description":37,"armGroupLabels":38},"Placebo","Placebo IV injection",[39],"Placebo in combination with azacitidine",{"type":29,"name":41,"description":42,"armGroupLabels":43},"Azacitidine","Azacitidine SC injection",[33,34,39],[45],{"measure":46,"description":47,"timeFrame":48},"Complete remission rate (CRR)","CRR is defined as the proportion of subjects with complete remission (CR) per International Working Group (IWG) 2023 criteria","Up to approximately 2 years",[50,53,56,59,62,65,68,71,74,77],{"measure":51,"description":52,"timeFrame":48},"Overall response rate (ORR)","The proportion of subjects with recorded response per IWG 2023",{"measure":54,"description":55,"timeFrame":48},"Time to response (TTR)","Time from the randomization to the first recorded response",{"measure":57,"description":58,"timeFrame":48},"Time to CR (TTCR)","Time from the randomization to the first recorded CR",{"measure":60,"description":61,"timeFrame":48},"Duration of response (DoR)","Time from the first recorded response until disease relapse or progression or death due to any cause, whichever occurs first",{"measure":63,"description":64,"timeFrame":48},"Duration of CR (DoCR)","Time from the first recorded CR until disease relapse or progression or death due to any cause, whichever occurs first",{"measure":66,"description":67,"timeFrame":48},"Event-free survival (EFS)","Time from randomization until transformation to AML or death due to any cause, whichever occurs first",{"measure":69,"description":70,"timeFrame":48},"Overall survival (OS)","The time from randomization until death due to any cause",{"measure":72,"description":73,"timeFrame":48},"Number of subjects with adverse events (AEs)","An AE is any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment",{"measure":75,"description":76,"timeFrame":48},"Pharmacokinetic characteristics","Serum concentrations of AK117 in individual subjects at different time points after AK117 administration",{"measure":78,"description":79,"timeFrame":48},"Anti-drug antibody (ADA)","Number of subjects with detectable anti-drug antibodies","ALL","18 Years",false,{"inclusion":84,"exclusion":94,"raw_text":105},[85,86,87,88,89,90,91,92,93],"Age ≥ 18 years old at the time of enrolment.","Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.","Expected life expectancy ≥ 3 months.","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.","Ability to undergo the study-required bone marrow sample collection procedures.","Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity).","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.","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.","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.",[95,96,97,98,99,100,101,102,103,104],"MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplastic\u002Fmyeloproliferative neoplasms (MDS\u002FMPN).","Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.","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.","Patients who previously diagnosed with another malignancy and have any evidence of residual disease.","Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies.","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.","Patients with current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.","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.","Patients who are breastfeeding or plans to breastfeed during the study.","Other conditions where the investigator considers the patient inappropriate for enrollment.","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.",[107,108],"ADULT","OLDER_ADULT",[110,119,127,135,143,151,158,166,174,182,190,197,210,218,230],{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":115,"geoPoint":116},"UCLA Ronald Reagan Medical Center","Los Angeles","California","90095","United States",{"lat":117,"lon":118},34.05223,-118.24368,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":115,"geoPoint":124},"Rocky Mountain Cancer Centers","Aurora","Colorado","80012",{"lat":125,"lon":126},39.72943,-104.83192,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":115,"geoPoint":132},"Yale Cancer Center","New Haven","Connecticut","06510",{"lat":133,"lon":134},41.30815,-72.92816,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":115,"geoPoint":140},"Mid Florida Hematology and Oncology Center","Orange City","Florida","32763",{"lat":141,"lon":142},28.94888,-81.29867,{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":115,"geoPoint":148},"American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)","Bethesda","Maryland","20817",{"lat":149,"lon":150},38.98067,-77.10026,{"facility":152,"status":8,"city":153,"state":146,"zip":154,"country":115,"geoPoint":155},"Maryland Oncology-Columbia","Columbia","21044",{"lat":156,"lon":157},39.24038,-76.83942,{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":115,"geoPoint":163},"Washington University School of Medicine in St. Louis","St Louis","Missouri","63110",{"lat":164,"lon":165},38.62727,-90.19789,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":115,"geoPoint":171},"Montefiore Einstein Comprehensive Cancer Center","The Bronx","New York","10467",{"lat":172,"lon":173},40.84985,-73.86641,{"facility":175,"status":8,"city":176,"state":177,"zip":178,"country":115,"geoPoint":179},"UNC Lineberger Comprehensive Cancer Center","Chapel Hill","North Carolina","27514",{"lat":180,"lon":181},35.9132,-79.05584,{"facility":183,"status":8,"city":184,"state":185,"zip":186,"country":115,"geoPoint":187},"Gabrail Cancer Center","Canton","Ohio","44718",{"lat":188,"lon":189},40.79895,-81.37845,{"facility":191,"status":8,"city":192,"state":185,"zip":193,"country":115,"geoPoint":194},"Ohio State University","Columbus","43210",{"lat":195,"lon":196},39.96118,-82.99879,{"facility":198,"status":8,"city":199,"state":200,"zip":201,"country":115,"contacts":202,"geoPoint":207},"Oncology Associates of Oregon","Eugene","Oregon","97401",[203],{"name":204,"role":205,"email":206},"Luke Fletcher","CONTACT","luke.fletcher@usoncology.com",{"lat":208,"lon":209},44.05207,-123.08675,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":115,"geoPoint":215},"MUSC Hollings Cancer Center","Charleston","South Carolina","29425",{"lat":216,"lon":217},32.77632,-79.93275,{"facility":219,"status":8,"city":220,"state":221,"zip":222,"country":115,"contacts":223,"geoPoint":227},"UT Southwestern Medical Center","Dallas","Texas","75390-9065",[224],{"name":225,"role":205,"email":226},"Yazan Madanat","yazan.madanat@utsouthwestern.edu",{"lat":228,"lon":229},32.78306,-96.80667,{"facility":231,"status":8,"city":232,"country":233,"contacts":234,"geoPoint":237},"Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college","Tianjin","China",[235],{"name":236,"role":205},"Zhijian Xiao",{"lat":238,"lon":239},39.14222,117.17667,[241],{"name":242,"role":205,"phone":243,"email":244},"Wenting Li, MD","(+86)18116403289","wenting01.li@akesobio.com",[],[],[],{"nct_id":4,"conditions":249,"biomarkers":251},[250],"Myelodysplastic Syndrome",[],{"nct_id":4,"found":253,"summary":254,"prompt_version":264},true,{"design":255,"status":256,"heading":257,"summary":258,"follow_up":259,"word_count":260,"commitments":261,"compensation":262,"drugs_mentioned":263},"This is a Phase 2 study that is randomized, meaning you'll be assigned to a treatment group by chance. It's also double-blind, so neither you nor your doctors will know if you're receiving AK117 or the placebo. It involves multiple medical centers.","completed","A Study of AK117 with Azacitidine for Higher-Risk Myelodysplastic Syndromes","This study is testing a new drug called AK117 in combination with azacitidine for people with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). HR-MDS is a type of blood cancer where the bone marrow doesn't make enough healthy blood cells. Some participants will receive AK117 plus azacitidine, while others will receive a placebo (an inactive substance) plus azacitidine. The main goal is to see how many people achieve a complete remission (when signs of cancer disappear) over about two years. You might be able to join if you are at least 18 years old, have HR-MDS, and meet other health criteria. The study is currently unclear on its recruitment status and plans to enroll about 90 participants.","The study will measure complete remission rates for up to approximately 2 years.",116,"Not specified in the trial record.","Not stated in the trial record.",[30,36,41],"v2"]