[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554600":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":45,"locations":50,"responsibleParty":184,"collaborators":33,"id":186,"slug":33,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":33,"eligibilityCriteria":191,"healthyVolunteers":187,"sex":192,"minAge":193,"maxAge":33,"enrollmentInfo":194,"targetDuration":33,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":33,"overallStatus":53,"whyStopped":33,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"BlossomHill Therapeutics","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Cohort - Monotherapy","EXPERIMENTAL","BH-30236 Monotherapy for Dose Escalation",[13],"Drug: BH-30236",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Escalation Cohort - Combination with Venetoclax","BH-30236 in Combination with Venetoclax for Dose Escalation.",[13,18],"Drug: Venetoclax",{"label":20,"type":10,"description":21,"interventionNames":22},"Dose Expansion Cohort - Monotherapy","BH-30236 based on Monotherapy dose escalation data.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Dose Expansion Cohort - Combination with Venetoclax","BH-30236 in Combination with Venetoclax based on Dose Escalation data",[13,18],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","BH-30236","BH-30236 will be provided as either a 5 mg, 15 mg or 30 mg tablet. Participants will take BH-30236 tablets orally depending on their dose level assignment.",[15,9,24,20],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Venetoclax","Venetoclax will be provided as 10 mg, 50 mg or 100 mg tablets. Participants will take venetoclax orally per label instructions.",[15,24],[39],"venclexta, venclyxto",[41],{"name":42,"affiliation":43,"role":44},"Sponsor Contact","BlossomHill Therapeutics, Inc.","STUDY_DIRECTOR",[46],{"name":42,"role":47,"phone":48,"phoneExt":33,"email":49},"CONTACT","(858) 732-3880","clinicaltrials@bhtherapeutics.com",[51,64,73,82,92,101,111,121,132,142,154,164,174],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":33},"City of Hope Medical Center","RECRUITING","Duarte","California","91010","United States",{"type":59,"coordinates":60},"Point",[61,62],-117.97729,34.13945,{"lat":62,"lon":61},{"facility":65,"status":53,"city":66,"state":55,"zip":67,"country":57,"cosmosGeoPoint":68,"geoPoint":72,"contacts":33},"University of California Los Angeles","Los Angeles","90095",{"type":59,"coordinates":69},[70,71],-118.24368,34.05223,{"lat":71,"lon":70},{"facility":74,"status":53,"city":75,"state":55,"zip":76,"country":57,"cosmosGeoPoint":77,"geoPoint":81,"contacts":33},"Stanford Cancer Center","Palo Alto","94304",{"type":59,"coordinates":78},[79,80],-122.14302,37.44188,{"lat":80,"lon":79},{"facility":83,"status":53,"city":84,"state":85,"zip":86,"country":57,"cosmosGeoPoint":87,"geoPoint":91,"contacts":33},"Sylvester Comprehensive Cancer Center","Miami","Florida","33136",{"type":59,"coordinates":88},[89,90],-80.19366,25.77427,{"lat":90,"lon":89},{"facility":93,"status":53,"city":94,"state":85,"zip":95,"country":57,"cosmosGeoPoint":96,"geoPoint":100,"contacts":33},"Moffitt Cancer Center","Tampa","33612",{"type":59,"coordinates":97},[98,99],-82.45843,27.94752,{"lat":99,"lon":98},{"facility":102,"status":53,"city":103,"state":104,"zip":105,"country":57,"cosmosGeoPoint":106,"geoPoint":110,"contacts":33},"Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion","Chicago","Illinois","60611",{"type":59,"coordinates":107},[108,109],-87.65005,41.85003,{"lat":109,"lon":108},{"facility":112,"status":53,"city":113,"state":114,"zip":115,"country":57,"cosmosGeoPoint":116,"geoPoint":120,"contacts":33},"Roswell Park Cancer Institute","Buffalo","New York","14263",{"type":59,"coordinates":117},[118,119],-78.87837,42.88645,{"lat":119,"lon":118},{"facility":122,"status":53,"city":114,"state":114,"zip":123,"country":57,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Memorial Sloan Kettering Cancer Center","10065",{"type":59,"coordinates":125},[126,127],-74.00597,40.71427,{"lat":127,"lon":126},[130],{"name":131,"role":47,"phone":33,"phoneExt":33,"email":33},"Study Coordinator",{"facility":133,"status":53,"city":134,"state":135,"zip":136,"country":57,"cosmosGeoPoint":137,"geoPoint":141,"contacts":33},"The Ohio State University Wexner Medical Center - James Cancer Hosp","Columbus","Ohio","43210",{"type":59,"coordinates":138},[139,140],-82.99879,39.96118,{"lat":140,"lon":139},{"facility":143,"status":53,"city":144,"state":145,"zip":146,"country":57,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"type":59,"coordinates":148},[149,150],-86.78444,36.16589,{"lat":150,"lon":149},[153],{"name":131,"role":47,"phone":33,"phoneExt":33,"email":33},{"facility":155,"status":53,"city":156,"state":157,"zip":158,"country":57,"cosmosGeoPoint":159,"geoPoint":163,"contacts":33},"The University of Texas M.D. Anderson Cancer Center","Houston","Texas","77030",{"type":59,"coordinates":160},[161,162],-95.36327,29.76328,{"lat":162,"lon":161},{"facility":165,"status":53,"city":166,"state":167,"zip":168,"country":57,"cosmosGeoPoint":169,"geoPoint":173,"contacts":33},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":59,"coordinates":170},[171,172],-122.33207,47.60621,{"lat":172,"lon":171},{"facility":175,"status":53,"city":176,"state":177,"zip":178,"country":57,"cosmosGeoPoint":179,"geoPoint":183,"contacts":33},"University of Wisconsin Clinical Science Center","Madison","Wisconsin","53792",{"type":59,"coordinates":180},[181,182],-89.40123,43.07305,{"lat":182,"lon":181},{"type":185,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100554600",false,"NCT06501196","A Study of BH-30236 in Relapsed\u002F Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome","A Phase 1\u002F1b Open-Label, Dose Escalation, First-in- Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase (CLK) Inhibitor, BH-30236, in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (R\u002FR AML) or Higher-Risk Myelodysplastic Syndrome (HR-MDS)","Inclusion criteria:\n\n* ≥18 years.\n* Diagnosis of relapsed\u002Frefractory acute myelogenous leukemia (R\u002FR) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion.\n* Prior treatment history must include 1-5 prior lines of therapy.\n* ECOG performance status ≤2.\n* Adequate organ function evidenced by the following laboratory values:\n* Hepatic: Transaminase levels aspartate aminotransferase \\[AST\\]\u002F alanine transaminase \\[ALT\\] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT \\\u003C 5.0 × ULN is acceptable. Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease.\n* Renal: Measured or calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula)\n\nThe above are a summary, other inclusion criteria details may apply.\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.\n* Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;\n* Active and uncontrolled infections.\n* Unresolved AEs greater than Grade from prior therapies.\n* History of other active malignancy (with certain exceptions)\n* Prior treatment with a CLK inhibitor.\n* Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less.\n\nThe above is a summary, other exclusion criteria details may apply.","ALL","18 Years",{"count":195,"type":196},170,"ESTIMATED","INTERVENTIONAL",[199],"PHASE1","Study BH-30236-01 is a first-in-human (FIH), Phase 1\u002F1b, open-label, dose escalation and expansion study in participants with relapsed\u002Frefractory acute myelogenous leukemia (R\u002FR AML) or higher-risk myelodysplastic syndrome (HR-MDS).\n\nPhase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy.\n\nPhase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax.\n\nPhase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.",[202,203,204,205,206,207],"Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Preleukemia","Myelodysplastic Syndromes","Refractory Acute Myeloid Leukemia","2025-09-19",{"date":210,"type":211},"2025-09-24","ACTUAL",{"date":213,"type":211},"2024-06-19",{"date":215,"type":196},"2027-06",{"name":5,"class":6},13]