[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544732":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":49,"responsibleParty":146,"collaborators":30,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":30,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":30,"enrollmentInfo":157,"targetDuration":30,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":30,"overallStatus":52,"whyStopped":30,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Apollo Therapeutics Ltd","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Phase: APL-4098 monotherapy","EXPERIMENTAL","Dose escalation with different dosing levels of APL-4098.",[13],"Drug: APL-4098",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Escalation Phase: APL-4098 and azacitidine","Dose escalation with different dosing levels of APL-4098 in combination with azacitidine.",[18],"Drug: Azacitidine and APL-4098",{"label":20,"type":10,"description":21,"interventionNames":22},"APL-4098 and azacitidine and venetoclax","Dose escalation with different dosing levels of APL-4098 in combination with azacitidine and venetoclax.",[23],"Drug: Azacitidine and Venetoclax and APL-4098",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","APL-4098","APL-4098 is administered orally in 28-day cycles",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Azacitidine and APL-4098","Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; APL-4098 is administered orally.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Azacitidine and Venetoclax and APL-4098","Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; Venetoclax is administered orally; APL-4098 is administered orally.",[20],[40],{"name":41,"affiliation":42,"role":43},"Sanjay Aggarwal, MD","Apollo Therapeutics","STUDY_CHAIR",[45],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":48},"CONTACT","781-479-2267","AP30@apollotx.com",[50,64,73,82,93,102,117,126,135],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":30},"Monash Health","RECRUITING","Clayton","Victoria","3168","Australia","AU",{"type":59,"coordinates":60},"Point",[61,62],145.11667,-37.91667,{"lat":62,"lon":61},{"facility":65,"status":52,"city":66,"state":54,"zip":67,"country":56,"countryCode":57,"cosmosGeoPoint":68,"geoPoint":72,"contacts":30},"St. Vincent's Hospital Melbourne","Fitzroy","3065",{"type":59,"coordinates":69},[70,71],144.97833,-37.79839,{"lat":71,"lon":70},{"facility":74,"status":52,"city":75,"state":54,"zip":76,"country":56,"countryCode":57,"cosmosGeoPoint":77,"geoPoint":81,"contacts":30},"The Alfred Hospital","Melbourne","3004",{"type":59,"coordinates":78},[79,80],144.96332,-37.814,{"lat":80,"lon":79},{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":56,"countryCode":57,"cosmosGeoPoint":88,"geoPoint":92,"contacts":30},"Hollywood Private Hospital","ACTIVE_NOT_RECRUITING","Nedlands","Western Australia","6009",{"type":59,"coordinates":89},[90,91],115.8073,-31.98184,{"lat":91,"lon":90},{"facility":94,"status":52,"city":95,"state":86,"zip":96,"country":56,"countryCode":57,"cosmosGeoPoint":97,"geoPoint":101,"contacts":30},"Royal Perth Hospital","Perth","6000",{"type":59,"coordinates":98},[99,100],115.8614,-31.95224,{"lat":100,"lon":99},{"facility":103,"status":52,"city":104,"state":30,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"University Hospital of Wales","Cardiff","CF14 4XW","United Kingdom","UK",{"type":59,"coordinates":109},[110,111],-3.18,51.48,{"lat":111,"lon":110},[114],{"name":115,"role":116,"phone":30,"phoneExt":30,"email":30},"Steven Knapper","PRINCIPAL_INVESTIGATOR",{"facility":118,"status":52,"city":119,"state":30,"zip":120,"country":106,"countryCode":107,"cosmosGeoPoint":121,"geoPoint":125,"contacts":30},"Beatson West of Scotland Cancer Centre","Glasgow","G120YN",{"type":59,"coordinates":122},[123,124],-4.25763,55.86515,{"lat":124,"lon":123},{"facility":127,"status":52,"city":128,"state":30,"zip":129,"country":106,"countryCode":107,"cosmosGeoPoint":130,"geoPoint":134,"contacts":30},"The Royal Marsden Hospital","London","SM2 5PT",{"type":59,"coordinates":131},[132,133],-0.12574,51.50853,{"lat":133,"lon":132},{"facility":136,"status":52,"city":128,"state":30,"zip":137,"country":106,"countryCode":107,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"Sarah Cannon Research Institute UK","W1G 0PU",{"type":59,"coordinates":139},[132,133],{"lat":133,"lon":132},[142],{"name":143,"role":46,"phone":144,"phoneExt":30,"email":145},"Sarah Cannon Research Institute","0044 203 21 95 200","enquiries.SCRI@hcahealthcare.co.uk",{"type":147,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100544732","phase-1-a-study-to-investigate-apl-4098-alone-and-in-combination-in-adults-with-aml-or-mds-100544732",false,"NCT06372717","A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS","A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome\u002FAML (MDS\u002FAML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R\u002FR AML), myelodysplastic syndrome (MDS)\u002F AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R\u002FR AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit.\n* WBC count ≤ 25,000\u002Fmicroliter\n* ECOG Performance Status of ≤ 2\n* Weight ≥ 40kg\n* Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse\n* Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study\n* Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial\n\nExclusion Criteria:\n\n* Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening\n* Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening\n* Diagnostic assessments: Left ventricular ejection fraction \\\u003C 45%, Fridericia's corrected QT interval \\> 470msec, Aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 x upper limit of normal (ULN), total bilirubin \\> 1.5 x ULN, calculated or measured creatinine clearance \\\u003C 45 mL\u002Fminute (multiply by 0.85 if female)\n* Infectious disease: HIV positive, active hepatitis B and\u002For C","ALL","18 Years",{"count":158,"type":159},100,"ESTIMATED","INTERVENTIONAL",[162],"PHASE1","This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)\u002FAML and MDS-excess blasts (EB).",[165,166,167,168,169],"Acute Myeloid Leukemia Refractory","Myelodysplastic Syndrome Acute Myeloid Leukemia","Myelodysplastic Syndrome With Excess Blasts","Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia (AML)","2026-05-29",{"date":172,"type":173},"2026-06-01","ACTUAL",{"date":175,"type":173},"2024-06-04",{"date":177,"type":159},"2027-05-01",{"name":5,"class":6},9]