[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567751":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":98,"collaborators":19,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":19,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":19,"enrollmentInfo":109,"targetDuration":19,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":19,"overallStatus":118,"whyStopped":19,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},{"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",[27,45,55,68,83],{"facility":28,"status":19,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Peking University People's Hospital","Beijing","Beijing Municipality","100044","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":44},"Li Zhou, Doctor","13816510379","13816510379Lizhou999_999@126.com",{"facility":46,"status":19,"city":47,"state":48,"zip":49,"country":32,"countryCode":33,"cosmosGeoPoint":50,"geoPoint":54,"contacts":19},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","530021",{"type":35,"coordinates":51},[52,53],108.31667,22.81667,{"lat":53,"lon":52},{"facility":56,"status":19,"city":57,"state":58,"zip":19,"country":32,"countryCode":33,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":35,"coordinates":60},[61,62],113.64861,34.75778,{"lat":62,"lon":61},[65],{"name":66,"role":23,"phone":67,"phoneExt":19,"email":19},"Jian Huang, Doctor","13588010568",{"facility":69,"status":19,"city":70,"state":71,"zip":72,"country":32,"countryCode":33,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200025",{"type":35,"coordinates":74},[75,76],121.45806,31.22222,{"lat":76,"lon":75},[79],{"name":80,"role":23,"phone":81,"phoneExt":19,"email":82},"YanLi Zhang, Doctor","13203729690","13203729690@163.com",{"facility":84,"status":19,"city":85,"state":86,"zip":87,"country":32,"countryCode":33,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"The First Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","310006",{"type":35,"coordinates":89},[90,91],120.16142,30.29365,{"lat":91,"lon":90},[94],{"name":95,"role":23,"phone":96,"phoneExt":19,"email":97},"ZhenFang Liu, Doctor","13481082237","liuliuzhenfang@163.com",{"type":99,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100567751","phase-1-a-clinical-trial-to-evaluate-the-safety-and-tolerability-of-tqb3911-tablets-in-patients-with-bcrabl-fusion-gene-positive-leukemia-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":110,"type":111},120,"ESTIMATED","INTERVENTIONAL",[114],"PHASE1","Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.",[117],"Chronic Myelogenous Leukemia","NOT_YET_RECRUITING","2024-10-31",{"date":121,"type":122},"2024-11-04","ACTUAL",{"date":124,"type":111},"2024-11",{"date":126,"type":111},"2026-12",{"name":128,"class":6},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",5]