[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BlossomHill Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100570348","phase-1-a-study-of-bh-30643-in-subjects-with-locally-advanced-or-metastatic-nsclc-harboring-egfr-andor-her2-mutations-100570348",false,"NCT06706076","A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and\u002For HER2 Mutations","A Phase 1\u002F2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and\u002For HER2 Mutations (SOLARA)","SOLARA","Inclusion Criteria:\n\n* ≥ 18 years or legal adult.\n* Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.\n* Had received standard therapies.\n* Has at least 1 measurable target extracranial lesion according to RECIST v1.1.\n* Eastern Cooperative Oncology Group Performance Status ≤ 1.\n* Has a life expectancy of ≥ 3 months.\n* Has adequate hematologic, hepatic, and renal function. \\*The above are a summary; other Inclusion Criteria details may apply.\n\nExclusion Criteria:\n\n* History of any concurrent malignancy within the previous 2 years.\n* Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).\n* Unresolved toxicities from prior therapies.\n* Any significant and uncontrolled medical condition, such as infection.\n* History of interstitial lung disease from any cause\n* Clinically significant cardiovascular event within 6 months or significant history of major organ.\n* Actively receiving investigational therapy(ies) in another clinical study. \\*The above are a summary; other Exclusion Criteria details may apply.","ALL","18 Years",{"count":20,"type":21},266,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This Phase1\u002F2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and\u002For HER2 mutations.\n\nPhase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.\n\nPhase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR\u002FHER2 mutation subtypes and\u002For treatment history at the RP2D, as well as the population PK.",[28],"NSCLC (Advanced Non-small Cell Lung Cancer)",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70],"NSCLC","Locally Advanced NSCLC","Metastatic NSCLC","Non-small Cell Lung Cancer","HER2 mutation","EGFR mutation","EGFR classical mutation","EGFR atypical mutation","EGFR exon20 insertion","EGFR uncommon mutation","EGFR resistant mutation","BH-30643","Tyrosine kinase inhibitor","TKI","EGFR","OMNI-EGFR","EGFR kinase domain mutations","EGFR common mutation","EGFR activating mutation","Ex19del","EGFR del E746_A750","Exon 19 deletion","L858R","C797S","C797G","C797X","T790M","G719X","G724X","L718V","L718X","L861Q","S768I","S768X","E709X","L747X","Exon 19 insertion","L833X","L861X","V769X","V834X","RECRUITING","2026-04-22",{"date":74,"type":75},"2026-04-24","ACTUAL",{"date":77,"type":75},"2025-01-09",{"date":79,"type":21},"2029-07-31",{"name":81,"class":82},"BlossomHill Therapeutics","INDUSTRY",41,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100554600","phase-1-a-study-of-bh-30236-in-relapsed-refractory-acute-myelogenous-leukemia-and-higher-risk-myelodysplastic-syndrome-100554600","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.",{"count":92,"type":21},170,[24],"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.",[96,97,98,99,100,101],"Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Preleukemia","Myelodysplastic Syndromes","Refractory Acute Myeloid Leukemia","2025-09-19",{"date":104,"type":75},"2025-09-24",{"date":106,"type":75},"2024-06-19",{"date":108,"type":21},"2027-06",{"name":81,"class":82},13,""]