[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544277":3},{"organization":4,"armGroups":7,"interventions":68,"overallOfficials":74,"centralContacts":79,"locations":85,"responsibleParty":389,"collaborators":16,"id":391,"slug":392,"hasResults":393,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":16,"eligibilityCriteria":397,"healthyVolunteers":393,"sex":398,"minAge":399,"maxAge":16,"enrollmentInfo":400,"targetDuration":16,"studyType":403,"phases":404,"briefSummary":406,"conditions":407,"keywords":16,"overallStatus":88,"whyStopped":16,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},{"fullName":5,"class":6},"Lomond Therapeutics Holdings, Inc.","INDUSTRY",[8,14,18,21,24,27,30,34,37,40,43,46,49,52,55,58,61,65],{"label":9,"type":10,"description":11,"interventionNames":12},"ZE46-0134 Dose Level -1","EXPERIMENTAL","Optional and would only be performed Dose Level 1 is poorly tolerated",[13],"Drug: ZE46-0134",{"label":15,"type":10,"description":16,"interventionNames":17},"ZE46-0134 Dose Level 1",null,[13],{"label":19,"type":10,"description":16,"interventionNames":20},"ZE46-0134 Dose Level 2",[13],{"label":22,"type":10,"description":16,"interventionNames":23},"ZE46-0134 Dose Level 3",[13],{"label":25,"type":10,"description":16,"interventionNames":26},"ZE46-0134 Dose Level 4",[13],{"label":28,"type":10,"description":16,"interventionNames":29},"ZE46-0134 Dose Level 5",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"ZE46-0134 Selected dose 1","The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study and will not exceed a loading dose of 150 mg x 2 days and maintenance dose of 50 mg QD",[13],{"label":35,"type":10,"description":32,"interventionNames":36},"ZE46-0134 Selected dose 2",[13],{"label":38,"type":10,"description":16,"interventionNames":39},"ZE46-0134 Dose Level 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Kansas","Lawrence","Kansas","66160",{"type":95,"coordinates":147},[148,149],-95.23525,38.97167,{"lat":149,"lon":148},[152],{"name":153,"role":82,"phone":16,"phoneExt":16,"email":16},"Lin",{"facility":155,"status":88,"city":156,"state":157,"zip":158,"country":92,"countryCode":93,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"University of Maryland","College Park","Maryland","20742",{"type":95,"coordinates":160},[161,162],-76.93692,38.98067,{"lat":162,"lon":161},[165],{"name":166,"role":82,"phone":16,"phoneExt":16,"email":16},"Baer",{"facility":168,"status":88,"city":169,"state":169,"zip":170,"country":92,"countryCode":93,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Memorial Sloan Kettering Cancer Center","New York","10065",{"type":95,"coordinates":172},[173,174],-74.00597,40.71427,{"lat":174,"lon":173},[177],{"name":178,"role":82,"phone":16,"phoneExt":16,"email":16},"Stein",{"facility":180,"status":88,"city":181,"state":182,"zip":183,"country":92,"countryCode":93,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"University of North Carolina","Chapel Hill","North Carolina","27514",{"type":95,"coordinates":185},[186,187],-79.05584,35.9132,{"lat":187,"lon":186},[190],{"name":191,"role":82,"phone":16,"phoneExt":16,"email":16},"Zeidner",{"facility":193,"status":88,"city":194,"state":195,"zip":196,"country":92,"countryCode":93,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"University of Cincinnati","Cincinnati","Ohio","45219",{"type":95,"coordinates":198},[199,200],-84.51439,39.12711,{"lat":200,"lon":199},[203],{"name":204,"role":82,"phone":16,"phoneExt":16,"email":16},"Curran",{"facility":206,"status":88,"city":207,"state":195,"zip":208,"country":92,"countryCode":93,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"The Ohio State University","Columbus","43210",{"type":95,"coordinates":210},[211,212],-82.99879,39.96118,{"lat":212,"lon":211},[215],{"name":216,"role":82,"phone":16,"phoneExt":16,"email":16},"Handa",{"facility":218,"status":88,"city":219,"state":220,"zip":221,"country":92,"countryCode":93,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Oregon Health & Science 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3583","s.fleming2@alfred.org.au",{"facility":261,"status":88,"city":245,"state":246,"zip":262,"country":248,"countryCode":249,"cosmosGeoPoint":263,"geoPoint":265,"contacts":266},"Eastern Health - Box Hill Hospital","3128",{"type":95,"coordinates":264},[252,253],{"lat":253,"lon":252},[267],{"name":268,"role":82,"phone":269,"phoneExt":16,"email":270},"Tse-Chieh Teh, Dr.","+61 425 326 804","t.teh@alfred.org.au",{"facility":272,"status":88,"city":273,"state":274,"zip":275,"country":248,"countryCode":249,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Linear Clinical Research Ltd","Perth","Western Australia","6009",{"type":95,"coordinates":277},[278,279],115.8614,-31.95224,{"lat":279,"lon":278},[282],{"name":76,"role":82,"phone":16,"phoneExt":16,"email":16},{"facility":284,"status":285,"city":286,"state":287,"zip":288,"country":289,"countryCode":16,"cosmosGeoPoint":16,"geoPoint":16,"contacts":290},"Gachon University Gil Medical Center","NOT_YET_RECRUITING","Incheon","Gyeonggi-do","21565","South Korea",[291],{"name":292,"role":82,"phone":293,"phoneExt":16,"email":294},"Kwai Han Yoo","82-32-458-2752","khyoo@gilhospital.com",{"facility":296,"status":285,"city":297,"state":16,"zip":298,"country":289,"countryCode":16,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Korea University Anam Hospital","Seoul","02841",{"type":95,"coordinates":300},[301,302],126.9784,37.566,{"lat":302,"lon":301},[305],{"name":306,"role":82,"phone":307,"phoneExt":16,"email":308},"Yong Park","82-2-920-5981","paark76@hanmail.net",{"facility":310,"status":285,"city":297,"state":16,"zip":311,"country":289,"countryCode":16,"cosmosGeoPoint":312,"geoPoint":314,"contacts":315},"Seoul National University Hospital","03080",{"type":95,"coordinates":313},[301,302],{"lat":302,"lon":301},[316],{"name":317,"role":82,"phone":318,"phoneExt":16,"email":319},"Dong-Yeop Shin","82-2-2072-7209","shindongyeop@snu.ac.kr",{"facility":321,"status":285,"city":297,"state":16,"zip":322,"country":289,"countryCode":16,"cosmosGeoPoint":323,"geoPoint":325,"contacts":326},"The Catholic University of Korea Seoul St. Mary's Hospital","06591",{"type":95,"coordinates":324},[301,302],{"lat":302,"lon":301},[327],{"name":328,"role":82,"phone":329,"phoneExt":16,"email":330},"Hee-Je Kim","82-2-2258-6054","cumckim@catholic.ac.kr",{"facility":332,"status":285,"city":333,"state":16,"zip":334,"country":335,"countryCode":336,"cosmosGeoPoint":337,"geoPoint":341,"contacts":342},"Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare","New Taipei City","235041","Taiwan","TW",{"type":95,"coordinates":338},[339,340],121.45703,25.06199,{"lat":340,"lon":339},[343],{"name":344,"role":82,"phone":345,"phoneExt":16,"email":346},"Yao-Yu Hsieh","886-970-746-920","alecto39@gmail.com",{"facility":348,"status":285,"city":349,"state":16,"zip":350,"country":335,"countryCode":336,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"China Medical University Hospital","Taichung","404327",{"type":95,"coordinates":352},[353,354],120.6839,24.1469,{"lat":354,"lon":353},[357],{"name":358,"role":82,"phone":359,"phoneExt":16,"email":360},"Su-Peng Yeh","886-975-680-836","supengyeh@gmail.com",{"facility":362,"status":285,"city":363,"state":16,"zip":364,"country":335,"countryCode":336,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"National Cheng Kung University Hospital","Tainan","704302",{"type":95,"coordinates":366},[367,368],120.21333,22.99083,{"lat":368,"lon":367},[371],{"name":372,"role":82,"phone":373,"phoneExt":16,"email":374},"Tsai-Yun Chen","886-936-257-940","teresa@mail.ncku.edu.tw",{"facility":376,"status":285,"city":377,"state":16,"zip":378,"country":335,"countryCode":336,"cosmosGeoPoint":379,"geoPoint":383,"contacts":384},"Taichung Veterans General Hospital","Xitun","407219",{"type":95,"coordinates":380},[381,382],120.64259,24.18021,{"lat":382,"lon":381},[385],{"name":386,"role":82,"phone":387,"phoneExt":16,"email":388},"Po-Wei Liao","886-988-063-468","rs60809st@hotmail.com",{"type":390,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100544277","phase-1-dose-escalation-and-expansion-study-to-evaluate-the-safety-pk-pd-and-efficacy-of-ze46-0134-in-adults-with-flt3-mutated-or-spliceosome-mutated-relapsed-or-refractory-acute-myeloid-leukemia-100544277",false,"NCT06366789","Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1, Open-label, Dose Escalation and Dose Expansion, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).\n2. Patient is ≥18 years of age at the time of obtaining informed consent.\n3. Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).\n4. Group 1: Patient must have a confirmed FLT3-ITD or FLT3-TKD mutation by central laboratory testing. Group 2: Patient must have a documented SF3B1, SRSF2, U2AF1, or ZRSR2 pathogenic mutation by local lab sequencing.\n5. For Group 1 only: Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator, or chosen not to have treatment with Gilteritinib for social reasons.\n6. Patients have a life expectancy of at least 3 months in the opinion of the Investigator.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n8. Patient must meet the following criteria as indicated on the clinical laboratory tests:\n\n   1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN)\n   2. Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease\n   3. Estimated glomerular filtration (eGFR) rate of \\>50 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease equation.\n9. Female patients:\n\n   1. If of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or\n   2. If of childbearing potential, must:\n\n   i. Have a negative serum pregnancy test at the Screening visit and urine pregnancy test on admission to the clinic on Day-1.\n\n   ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 45 days after the last dose of study drug.\n\n   iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from Screening until at least 45 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle).\n10. Male patients and their female spouse\u002Fpartners who are of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (at least 1of which must be a barrier method) starting at Screening and continue throughout the study period and for 45 days after the final study drug administration. Male patient must not donate sperm starting at Screening and throughout the study period and for 45 days after the final study drug administration.\n\nExclusion Criteria:\n\n1. Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).\n2. Patient is ≥18 years of age at the time of obtaining informed consent.\n3. Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).\n4. Patient must have a confirmed FLT3 ITD, TKD or ITD-F691L mutation documented within the past 90 days in absence of therapy or within the Screening period 28 days) prior to study drug administration on C1D1 if therapy has been given.\n5. Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator, or chosen not to have treatment with Gilteritinib for social reasons.\n6. Patients have a life expectancy of at least 3 months in the opinion of the Investigator.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n8. Patient must meet the following criteria as indicated on the clinical laboratory tests:\n\n   1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN)\n   2. Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease\n   3. Estimated glomerular filtration (eGFR) rate of \\>50 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease equation.\n9. Female patients:\n\n   1. If of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or\n   2. If of childbearing potential, must:\n\n   i. Have a negative serum pregnancy test at the Screening visit and urine pregnancy test on admission to the clinic on Day-1.\n\n   ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 45 days after the last dose of study drug.\n\n   iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from Screening until at least 45 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle).\n10. Male patients and their female spouse\u002Fpartners who are of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (at least 1of which must be a barrier method) starting at Screening and continue throughout the study period and for 45 days after the final study drug administration. Male patient must not donate sperm starting at Screening and throughout the study period and for 45 days after the final study drug administration.\n\nExclusion criteria\n\n1. Diagnosis of isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML)\n2. Acute promyelocytic leukemia (FAB M3)\n3. Active central nervous system (CNS) involvement by AML\n4. Clinical signs\u002Fsymptoms of leukostasis requiring urgent therapy\n5. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy\n6. Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.\n7. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by the local regulatory authority.\n8. Systemic antineoplastic therapy within 5 half-lives or radiation therapy within 1 week prior to starting protocol with the exception of hydroxyurea, which is allowed to control white blood cell counts.\n9. Female patients who are pregnant or lactating\n10. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the study.\n11. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment (Troponin (regular or high sensitivity) leak alone not included if no residual dysfunction), New York Heart Association (NYHA) Class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n12. Infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control in the opinion of the Investigator. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control.","ALL","18 Years",{"count":401,"type":402},150,"ESTIMATED","INTERVENTIONAL",[405],"PHASE1","This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia",[408],"AML With Gene Mutations","2025-12-24",{"date":411,"type":412},"2025-12-31","ACTUAL",{"date":414,"type":412},"2024-05-29",{"date":416,"type":402},"2027-12",{"name":5,"class":6},23]