[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518725":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":105,"collaborators":25,"id":107,"slug":25,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":25,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":25,"enrollmentInfo":115,"targetDuration":25,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Vincerx Pharma, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation of VIP943 (QW)","EXPERIMENTAL","Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW).",[13],"Drug: VIP943 (QW)",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Escalation of VIP943 (BIW)","Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration twice weekly (BIW).",[18],"Drug: VIP943 (BIW)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","VIP943 (QW)","VIP943 will be administered by IV Infusion weekly",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"VIP943 (BIW)","VIP943 will be administered by IV Infusion bi-weekly",[15],[31],{"name":32,"affiliation":5,"role":33},"Vincerx Study Director","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Vincerx Clinical Trials Contact","CONTACT","16508006676","clinicaltrials@vincerx.com",[41,57,69,81,93],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35233","United States",{"type":49,"coordinates":50},"Point",[51,52],-86.80249,33.52066,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":25,"phoneExt":25,"email":25},"Research Site",{"facility":58,"status":43,"city":59,"state":60,"zip":61,"country":47,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"University of Cincinnati","Cincinnati","Ohio","45219",{"type":49,"coordinates":63},[64,65],-84.51439,39.12711,{"lat":65,"lon":64},[68],{"name":56,"role":37,"phone":25,"phoneExt":25,"email":25},{"facility":70,"status":43,"city":71,"state":72,"zip":73,"country":47,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"TriStar Bone Marrow Transplant","Nashville","Tennessee","37203",{"type":49,"coordinates":75},[76,77],-86.78444,36.16589,{"lat":77,"lon":76},[80],{"name":56,"role":37,"phone":25,"phoneExt":25,"email":25},{"facility":82,"status":43,"city":83,"state":84,"zip":85,"country":47,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":49,"coordinates":87},[88,89],-95.36327,29.76328,{"lat":89,"lon":88},[92],{"name":56,"role":37,"phone":25,"phoneExt":25,"email":25},{"facility":94,"status":43,"city":95,"state":96,"zip":97,"country":47,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":49,"coordinates":99},[100,101],-122.33207,47.60621,{"lat":101,"lon":100},[104],{"name":56,"role":37,"phone":25,"phoneExt":25,"email":25},{"type":106,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100518725",false,"NCT06034275","Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies","An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP943 Monotherapy in Subjects With Advanced CD123+ Hematologic Malignancies","Inclusion Criteria:\n\n* Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.\n* Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (MDS) to allow for assessment of drug activity.\n* Evidence of CD123 expression from a local laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n\nExclusion Criteria:\n\n* Known central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Clinically significant cardiac disease including congestive heart failure \\> New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.","ALL","18 Years",{"count":116,"type":117},36,"ESTIMATED","INTERVENTIONAL",[120],"PHASE1","Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies",[123,124,125],"Acute Myeloid Leukemia","B-cell Acute Lymphoblastic Leukemia","High-risk Myelodysplastic Syndrome",[127,128,129,130,131,132,133,134,135,136],"ADC","Hematologic Malignancies","Leukemia","CD123","B-ALL","AML","MDS","Relapsed\u002F Refractory","Hematologic Diseases","Bone Marrow Diseases","2024-11-13",{"date":139,"type":140},"2024-11-15","ACTUAL",{"date":142,"type":140},"2023-09-13",{"date":144,"type":117},"2025-12-31",{"name":5,"class":6},5]