[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566134":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":135,"collaborators":26,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":26,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":26,"enrollmentInfo":146,"targetDuration":26,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"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",[46,59,68,77,88,97,106,117,126],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":26},"Concord Hospital","RECRUITING","Concord","2139","Australia","AU",{"type":54,"coordinates":55},"Point",[56,57],151.10381,-33.84722,{"lat":57,"lon":56},{"facility":60,"status":48,"city":61,"state":26,"zip":62,"country":51,"countryCode":52,"cosmosGeoPoint":63,"geoPoint":67,"contacts":26},"Peter MacCallum Cancer Centre","Melbourne","3000",{"type":54,"coordinates":64},[65,66],144.96332,-37.814,{"lat":66,"lon":65},{"facility":69,"status":48,"city":70,"state":26,"zip":71,"country":51,"countryCode":52,"cosmosGeoPoint":72,"geoPoint":76,"contacts":26},"Sir Charles Gairdner Hospital","Nedlands","6009",{"type":54,"coordinates":73},[74,75],115.8073,-31.98184,{"lat":75,"lon":74},{"facility":78,"status":48,"city":79,"state":26,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":26},"Institut Paoli-Calmettes","Marseille","13273","France","FR",{"type":54,"coordinates":84},[85,86],5.38107,43.29695,{"lat":86,"lon":85},{"facility":89,"status":48,"city":90,"state":26,"zip":91,"country":81,"countryCode":82,"cosmosGeoPoint":92,"geoPoint":96,"contacts":26},"CHRU de Strasbourg - Hopital de Hautepierre","Strasbourg","67200",{"type":54,"coordinates":93},[94,95],7.74553,48.58392,{"lat":95,"lon":94},{"facility":98,"status":48,"city":99,"state":26,"zip":100,"country":81,"countryCode":82,"cosmosGeoPoint":101,"geoPoint":105,"contacts":26},"Institut Claudius Regaud","Toulouse","31100",{"type":54,"coordinates":102},[103,104],1.44367,43.60426,{"lat":104,"lon":103},{"facility":107,"status":48,"city":108,"state":26,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":116,"contacts":26},"Hosp Univ Fund Jimenez Diaz","Madrid","28040","Spain","ES",{"type":54,"coordinates":113},[114,115],-3.70256,40.4165,{"lat":115,"lon":114},{"facility":118,"status":48,"city":119,"state":26,"zip":120,"country":110,"countryCode":111,"cosmosGeoPoint":121,"geoPoint":125,"contacts":26},"Clinica Univ. de Navarra","Pamplona","31008",{"type":54,"coordinates":122},[123,124],-1.64323,42.81687,{"lat":124,"lon":123},{"facility":127,"status":48,"city":128,"state":26,"zip":129,"country":110,"countryCode":111,"cosmosGeoPoint":130,"geoPoint":134,"contacts":26},"Hospital Universitario Virgen Rocio","Seville","41013",{"type":54,"coordinates":131},[132,133],-5.97317,37.38283,{"lat":133,"lon":132},{"type":136,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100566134","phase-1-a-study-of-jnj-90189892-for-relapsed-or-refractory-acute-myeloid-leukemia-or-myelodysplastic-neoplasms-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":147,"type":148},155,"ESTIMATED","INTERVENTIONAL",[151],"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).",[154,155],"Leukemia, Myeloid, Acute","Myelodysplastic Neoplasms","2026-06-04",{"date":158,"type":159},"2026-06-05","ACTUAL",{"date":161,"type":159},"2025-03-21",{"date":163,"type":148},"2028-11-21",{"name":5,"class":6},9]