[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567751":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":97,"collaborators":19,"id":99,"slug":19,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":19,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":19,"enrollmentInfo":107,"targetDuration":19,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":19,"overallStatus":116,"whyStopped":19,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TQB3911 tablets","EXPERIMENTAL","Once a day for 28 days as a treatment cycle",[13],"Drug: TQB3911 tablets",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","TQB3911 is a small molecule BCR::ABL1 allosteric inhibitor. By occupying the myristyl binding site, TQB3911 recovers the inhibition of BCR::ABL1 fusion protein kinase activity, and ultimately inhibits the proliferation of tumor cells.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Qian Jiang, Doctor","CONTACT","010-88326850","jiangqian@medmail.com.cn",[27,44,54,67,82],{"facility":28,"status":19,"city":29,"state":30,"zip":31,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Peking University People's Hospital","Beijing","Beijing Municipality","100044","China",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":19,"email":43},"Li Zhou, Doctor","13816510379","13816510379Lizhou999_999@126.com",{"facility":45,"status":19,"city":46,"state":47,"zip":48,"country":32,"cosmosGeoPoint":49,"geoPoint":53,"contacts":19},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","530021",{"type":34,"coordinates":50},[51,52],108.31667,22.81667,{"lat":52,"lon":51},{"facility":55,"status":19,"city":56,"state":57,"zip":19,"country":32,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":34,"coordinates":59},[60,61],113.64861,34.75778,{"lat":61,"lon":60},[64],{"name":65,"role":23,"phone":66,"phoneExt":19,"email":19},"Jian Huang, Doctor","13588010568",{"facility":68,"status":19,"city":69,"state":70,"zip":71,"country":32,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200025",{"type":34,"coordinates":73},[74,75],121.45806,31.22222,{"lat":75,"lon":74},[78],{"name":79,"role":23,"phone":80,"phoneExt":19,"email":81},"YanLi Zhang, Doctor","13203729690","13203729690@163.com",{"facility":83,"status":19,"city":84,"state":85,"zip":86,"country":32,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"The First Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","310006",{"type":34,"coordinates":88},[89,90],120.16142,30.29365,{"lat":90,"lon":89},[93],{"name":94,"role":23,"phone":95,"phoneExt":19,"email":96},"ZhenFang Liu, Doctor","13481082237","liuliuzhenfang@163.com",{"type":98,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100567751",false,"NCT06672263","A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia","Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed the informed consent, and had good compliance;\n* Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months;\n* During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination;\n* Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure)\n* The main organs function well\n* Female subjects of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Had or was currently suffering from other malignant tumors within 5 years before the first medication\n* Combined with active central nervous system leukemia\n* Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment\n* Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block\n* Acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication\n* History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia\n* Patients with CML-CP who have achieved complete cytogenetic response (CCyR)\n* Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation\n* Use of drugs that may have caused QT prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period","ALL","18 Years",{"count":108,"type":109},120,"ESTIMATED","INTERVENTIONAL",[112],"PHASE1","Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.",[115],"Chronic Myelogenous Leukemia","NOT_YET_RECRUITING","2024-10-31",{"date":119,"type":120},"2024-11-04","ACTUAL",{"date":122,"type":109},"2024-11",{"date":124,"type":109},"2026-12",{"name":126,"class":6},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",5]