[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556876":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":49,"overallStatus":54,"whyStopped":19,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":62,"locationsCount":19},{"fullName":5,"class":6},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-10382+Flumatinib","EXPERIMENTAL","Subjects with resistant or intolerant CML CP\u002FAP will be enrolled in dose-escalation stage.Dose escalation of HS-10382 combined flumatinib will be done to determine maximum tolerated dose(Part 1).\n\nDepending on data obtained from the dose-escalation stage,dose expansion may proceed with in subjects with newly diagnosed CML-CP.The safety and efficacy will be evaluated at the target dose.(Part 2)",[13],"Drug: HS-10382+Flumatinib",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Drug:HS-10382+Flumatinib HS-10382 is administered orally BID Drug:Flumatinib Flumatinib 400mg once daily",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Yu Hu, PhD","CONTACT","13986183871","dr_huyu@126.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100556876","phase-1-study-of-hs-10382-combination-in-patients-with-chronic-myeloid-leukemia-cml-100556876",false,"NCT06530810","Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML)","A Phase 1b, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10382 Combination Therapy in Patients With Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* Signed informed consent form.\n* Men or women aged more than or equal to (≥) 18 years, and less than (\\\u003C) 75 years.\n* CML-CP\u002FAP patients with the Ph chromosome or BCR-ABL1 fusion genes.\n* Patient with CML-CP\u002FAP who are resistant to or intolerant to previous TKIs therapy.\n* ECOG performance status of 0-1 and no worsening within 2 weeks before the first dose.\n* Life expectancy ≥ 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study; Females should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study.\n* Females must have evidence of non-childbearing potential.\n\nExclusion Criteria:\n\n* CML-CP patients who have acquired CCyR and have not lost it.\n* Patients with CML-CP who have progressed to AP or blast phase(BP.)\n* Patients with CML-AP who have obtained CHR or no evidence of CML in peripheral blood.\n* Patients with CML-AP who have progressed to BP.\n* Previous treatment with a BCR-ABL1 TKI allosteric inhibitor .\n* Impaired cardiac function including any one of the following:\n* Resting corrected QT interval (QTc) \\> 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).\n* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events,\n* Left ventricular ejection fraction (LVEF) ≤ 50%.\n* Myocardial infarction occurred within 6 months of the first scheduled dose of study drug.;\n* Congestive heart failure occurred within 6 months of the first scheduled dose of study drug.;\n* Uncontrollable angina.\n* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* Any severe or uncontrolled systemic diseases (i.e. uncontrolled hypertension or diabetes).\n* Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption.\n* Severe infection within 4 weeks prior to the first scheduled dose of study drug\n* Inadequate other organ function.\n* History of other malignancies.\n* History of hypersensitivity to any active or inactive ingredient of HS-10382 and flumatinib.\n* History of neuropathy or mental disorders, including epilepsy and dementia.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements","ALL","18 Years","75 Years",{"count":39,"type":40},100,"ESTIMATED","INTERVENTIONAL",[43],"PHASE1","HS-10382 is a small molecular, oral potent, allosteric inhibitor. By binding a myristoyl site of the BCR-ABL1 protein, HS-10382 locks BCR-ABL1 into an inactive conformation. Flumatinib is the first approved second generation TKI in China and a derivative of imatinib.\n\nThe primary objective of this study is to evaluation the safety and tolerability and of HS-10382 combination therapy in patients with chronic myeloid leukemia (CML).\n\nThe secondary objectives is to evaluate the PK profile, major metabolites and efficacy of HS-10382 in CML-CP\u002FAP subjects after combination therapy, and to explore the kinase domain mutations associated with TKI resistance",[46,47,48],"Chronic Myelogenous Leukemia","CML Chronic Phase","CML Accelerated Phase",[50,51,52,53],"CML-CP\u002FAP","HS-10382","Flumatinib","Allosteric inhibitor","NOT_YET_RECRUITING","2024-07-26",{"date":57,"type":58},"2024-07-31","ACTUAL",{"date":57,"type":40},{"date":61,"type":40},"2028-05-08",{"name":5,"class":6}]