[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518725":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":106,"collaborators":25,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":25,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":25,"enrollmentInfo":117,"targetDuration":25,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"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",[41,58,70,82,94],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-86.80249,33.52066,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":25,"phoneExt":25,"email":25},"Research Site",{"facility":59,"status":43,"city":60,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"University of Cincinnati","Cincinnati","Ohio","45219",{"type":50,"coordinates":64},[65,66],-84.51439,39.12711,{"lat":66,"lon":65},[69],{"name":57,"role":37,"phone":25,"phoneExt":25,"email":25},{"facility":71,"status":43,"city":72,"state":73,"zip":74,"country":47,"countryCode":48,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"TriStar Bone Marrow Transplant","Nashville","Tennessee","37203",{"type":50,"coordinates":76},[77,78],-86.78444,36.16589,{"lat":78,"lon":77},[81],{"name":57,"role":37,"phone":25,"phoneExt":25,"email":25},{"facility":83,"status":43,"city":84,"state":85,"zip":86,"country":47,"countryCode":48,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":50,"coordinates":88},[89,90],-95.36327,29.76328,{"lat":90,"lon":89},[93],{"name":57,"role":37,"phone":25,"phoneExt":25,"email":25},{"facility":95,"status":43,"city":96,"state":97,"zip":98,"country":47,"countryCode":48,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":50,"coordinates":100},[101,102],-122.33207,47.60621,{"lat":102,"lon":101},[105],{"name":57,"role":37,"phone":25,"phoneExt":25,"email":25},{"type":107,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100518725","phase-1-study-of-vip943-in-subjects-with-advanced-cd123-hematologic-malignancies-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":118,"type":119},36,"ESTIMATED","INTERVENTIONAL",[122],"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",[125,126,127],"Acute Myeloid Leukemia","B-cell Acute Lymphoblastic Leukemia","High-risk Myelodysplastic Syndrome",[129,130,131,132,133,134,135,136,137,138],"ADC","Hematologic Malignancies","Leukemia","CD123","B-ALL","AML","MDS","Relapsed\u002F Refractory","Hematologic Diseases","Bone Marrow Diseases","2024-11-13",{"date":141,"type":142},"2024-11-15","ACTUAL",{"date":144,"type":142},"2023-09-13",{"date":146,"type":119},"2025-12-31",{"name":5,"class":6},5]