[{"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 or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.\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.\n\n  * 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* Active or history of interstitial lung disease from any cause\n* Clinically significant cardiovascular event within 6 months or significant history of major organ.\n\n  * The above are a summary; other Exclusion Criteria details may apply.","ALL","18 Years",{"count":20,"type":21},675,"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, both as a monotherapy and in combination with chemotherapy.\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","2026-08-03",{"date":74,"type":75},"2026-08-05","ACTUAL",{"date":77,"type":75},"2025-01-09",{"date":79,"type":21},"2029-07-31",{"name":81,"class":82},"BlossomHill Therapeutics","INDUSTRY",42,{"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,""]