[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566134":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":132,"collaborators":26,"id":134,"slug":26,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":26,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":26,"enrollmentInfo":142,"targetDuration":26,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"JNJ-90189892: Monotherapy","EXPERIMENTAL","Participants will receive JNJ-90189892 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially based on the decisions of the study evaluation team (SET) until the recommended phase 2 dose (RP2D) has been identified. Participants in Part 2 (Dose expansion) will receive JNJ-90189892 at the RP2D determined in Part 1.",[13],"Drug: JNJ-90189892",{"label":15,"type":10,"description":16,"interventionNames":17},"JNJ-90189892: In Combination with Azacitadine (AZA)+ Venetoclax (VEN)","Participants with relapsed or refractory (R\u002FR) acute myeloid leukemia (AML) in Part 3 will receive JNJ-90189892+ AZA+VEN to determine the recommended Phase 2 combination dose (RP2CD). The starting JNJ-90189892 dose regimen in Part 3 will be at least 1 dose level below the highest dose level cleared in Part 1 as determined by the SET. In Part 4 participants with newly diagnosed (ND) AML will receive JNJ-90189892+ AZA+VEN starting from the JNJ-90189892 dose level determined safe in Part 3 by the SET.",[13,18,19],"Drug: Azacitadine (AZA)","Drug: Venetoclax (VEN)",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","JNJ-90189892","JNJ-90189892 will be administered.",[15,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Azacitadine (AZA)","AZA will be administered.",[15],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Venetoclax (VEN)","VEN will be administered.",[15],[36],{"name":37,"affiliation":5,"role":38},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[46,58,67,76,86,95,104,114,123],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":26},"Concord Hospital","RECRUITING","Concord","2139","Australia",{"type":53,"coordinates":54},"Point",[55,56],151.10381,-33.84722,{"lat":56,"lon":55},{"facility":59,"status":48,"city":60,"state":26,"zip":61,"country":51,"cosmosGeoPoint":62,"geoPoint":66,"contacts":26},"Peter MacCallum Cancer Centre","Melbourne","3000",{"type":53,"coordinates":63},[64,65],144.96332,-37.814,{"lat":65,"lon":64},{"facility":68,"status":48,"city":69,"state":26,"zip":70,"country":51,"cosmosGeoPoint":71,"geoPoint":75,"contacts":26},"Sir Charles Gairdner Hospital","Nedlands","6009",{"type":53,"coordinates":72},[73,74],115.8073,-31.98184,{"lat":74,"lon":73},{"facility":77,"status":48,"city":78,"state":26,"zip":79,"country":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":26},"Institut Paoli-Calmettes","Marseille","13273","France",{"type":53,"coordinates":82},[83,84],5.38107,43.29695,{"lat":84,"lon":83},{"facility":87,"status":48,"city":88,"state":26,"zip":89,"country":80,"cosmosGeoPoint":90,"geoPoint":94,"contacts":26},"CHRU de Strasbourg - Hopital de Hautepierre","Strasbourg","67200",{"type":53,"coordinates":91},[92,93],7.74553,48.58392,{"lat":93,"lon":92},{"facility":96,"status":48,"city":97,"state":26,"zip":98,"country":80,"cosmosGeoPoint":99,"geoPoint":103,"contacts":26},"Institut Claudius Regaud","Toulouse","31100",{"type":53,"coordinates":100},[101,102],1.44367,43.60426,{"lat":102,"lon":101},{"facility":105,"status":48,"city":106,"state":26,"zip":107,"country":108,"cosmosGeoPoint":109,"geoPoint":113,"contacts":26},"Hosp Univ Fund Jimenez Diaz","Madrid","28040","Spain",{"type":53,"coordinates":110},[111,112],-3.70256,40.4165,{"lat":112,"lon":111},{"facility":115,"status":48,"city":116,"state":26,"zip":117,"country":108,"cosmosGeoPoint":118,"geoPoint":122,"contacts":26},"Clinica Univ. de Navarra","Pamplona","31008",{"type":53,"coordinates":119},[120,121],-1.64323,42.81687,{"lat":121,"lon":120},{"facility":124,"status":48,"city":125,"state":26,"zip":126,"country":108,"cosmosGeoPoint":127,"geoPoint":131,"contacts":26},"Hospital Universitario Virgen Rocio","Seville","41013",{"type":53,"coordinates":128},[129,130],-5.97317,37.38283,{"lat":130,"lon":129},{"type":133,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100566134",false,"NCT06651229","A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms","A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms","Inclusion Criteria:\n\n* A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria\n* Body weight that is greater than or equals to (\\>=) 40 kg\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) \\>=40 milligrams per minute (mL\u002Fmin) computed with the calculator on the national kidney foundation website\n* Participants must have laboratory parameters in the required range\n\nExclusion Criteria:\n\n* Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation\n* Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted\n* All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients\n* Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892\n* Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment\n* Has known active central nervous system involvement","ALL","18 Years",{"count":143,"type":144},155,"ESTIMATED","INTERVENTIONAL",[147],"PHASE1","The purpose of Part 1 (Dose Escalation) of the study is to assess the effective dose (recommended Phase 2 dose\\[s\\] \\[RP2Ds\\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R\u002FR) acute myeloid leukemia (AML) or R\u002FR higher-risk type of myelodysplastic neoplasms (MDS \\[type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment\\]). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R\u002FR AML or higher-risk types of MDS at the RP2D regimen(s). The purpose of Part 3 and 4 is to assess the effective dose (recommended Phase 2 combination dose \\[RP2CD\\]) that can be safely administered, and dosing regimens of JNJ-90189892 in combination with azacitadine (AZA) + venetoclax (VEN) in participants with R\u002FR AML (part 3) and newly diagnosed (ND) AML (part 4).",[150,151],"Leukemia, Myeloid, Acute","Myelodysplastic Neoplasms","2026-06-04",{"date":154,"type":155},"2026-06-05","ACTUAL",{"date":157,"type":155},"2025-03-21",{"date":159,"type":144},"2028-11-21",{"name":5,"class":6},9]