[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554600":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":45,"locations":50,"responsibleParty":185,"collaborators":33,"id":187,"slug":188,"hasResults":189,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":33,"eligibilityCriteria":193,"healthyVolunteers":189,"sex":194,"minAge":195,"maxAge":33,"enrollmentInfo":196,"targetDuration":33,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":33,"overallStatus":53,"whyStopped":33,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"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",[51,65,74,83,93,102,112,122,133,143,155,165,175],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":33},"City of Hope Medical Center","RECRUITING","Duarte","California","91010","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-117.97729,34.13945,{"lat":63,"lon":62},{"facility":66,"status":53,"city":67,"state":55,"zip":68,"country":57,"countryCode":58,"cosmosGeoPoint":69,"geoPoint":73,"contacts":33},"University of California Los Angeles","Los Angeles","90095",{"type":60,"coordinates":70},[71,72],-118.24368,34.05223,{"lat":72,"lon":71},{"facility":75,"status":53,"city":76,"state":55,"zip":77,"country":57,"countryCode":58,"cosmosGeoPoint":78,"geoPoint":82,"contacts":33},"Stanford Cancer Center","Palo Alto","94304",{"type":60,"coordinates":79},[80,81],-122.14302,37.44188,{"lat":81,"lon":80},{"facility":84,"status":53,"city":85,"state":86,"zip":87,"country":57,"countryCode":58,"cosmosGeoPoint":88,"geoPoint":92,"contacts":33},"Sylvester Comprehensive Cancer Center","Miami","Florida","33136",{"type":60,"coordinates":89},[90,91],-80.19366,25.77427,{"lat":91,"lon":90},{"facility":94,"status":53,"city":95,"state":86,"zip":96,"country":57,"countryCode":58,"cosmosGeoPoint":97,"geoPoint":101,"contacts":33},"Moffitt Cancer Center","Tampa","33612",{"type":60,"coordinates":98},[99,100],-82.45843,27.94752,{"lat":100,"lon":99},{"facility":103,"status":53,"city":104,"state":105,"zip":106,"country":57,"countryCode":58,"cosmosGeoPoint":107,"geoPoint":111,"contacts":33},"Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion","Chicago","Illinois","60611",{"type":60,"coordinates":108},[109,110],-87.65005,41.85003,{"lat":110,"lon":109},{"facility":113,"status":53,"city":114,"state":115,"zip":116,"country":57,"countryCode":58,"cosmosGeoPoint":117,"geoPoint":121,"contacts":33},"Roswell Park Cancer Institute","Buffalo","New York","14263",{"type":60,"coordinates":118},[119,120],-78.87837,42.88645,{"lat":120,"lon":119},{"facility":123,"status":53,"city":115,"state":115,"zip":124,"country":57,"countryCode":58,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Memorial Sloan Kettering Cancer Center","10065",{"type":60,"coordinates":126},[127,128],-74.00597,40.71427,{"lat":128,"lon":127},[131],{"name":132,"role":47,"phone":33,"phoneExt":33,"email":33},"Study Coordinator",{"facility":134,"status":53,"city":135,"state":136,"zip":137,"country":57,"countryCode":58,"cosmosGeoPoint":138,"geoPoint":142,"contacts":33},"The Ohio State University Wexner Medical Center - James Cancer Hosp","Columbus","Ohio","43210",{"type":60,"coordinates":139},[140,141],-82.99879,39.96118,{"lat":141,"lon":140},{"facility":144,"status":53,"city":145,"state":146,"zip":147,"country":57,"countryCode":58,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"type":60,"coordinates":149},[150,151],-86.78444,36.16589,{"lat":151,"lon":150},[154],{"name":132,"role":47,"phone":33,"phoneExt":33,"email":33},{"facility":156,"status":53,"city":157,"state":158,"zip":159,"country":57,"countryCode":58,"cosmosGeoPoint":160,"geoPoint":164,"contacts":33},"The University of Texas M.D. Anderson Cancer Center","Houston","Texas","77030",{"type":60,"coordinates":161},[162,163],-95.36327,29.76328,{"lat":163,"lon":162},{"facility":166,"status":53,"city":167,"state":168,"zip":169,"country":57,"countryCode":58,"cosmosGeoPoint":170,"geoPoint":174,"contacts":33},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":60,"coordinates":171},[172,173],-122.33207,47.60621,{"lat":173,"lon":172},{"facility":176,"status":53,"city":177,"state":178,"zip":179,"country":57,"countryCode":58,"cosmosGeoPoint":180,"geoPoint":184,"contacts":33},"University of Wisconsin Clinical Science Center","Madison","Wisconsin","53792",{"type":60,"coordinates":181},[182,183],-89.40123,43.07305,{"lat":183,"lon":182},{"type":186,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100554600","phase-1-a-study-of-bh-30236-in-relapsed-refractory-acute-myelogenous-leukemia-and-higher-risk-myelodysplastic-syndrome-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":197,"type":198},170,"ESTIMATED","INTERVENTIONAL",[201],"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.",[204,205,206,207,208,209],"Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Preleukemia","Myelodysplastic Syndromes","Refractory Acute Myeloid Leukemia","2025-09-19",{"date":212,"type":213},"2025-09-24","ACTUAL",{"date":215,"type":213},"2024-06-19",{"date":217,"type":198},"2027-06",{"name":5,"class":6},13]