[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465502":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":83,"collaborators":24,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":24,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":24,"enrollmentInfo":94,"targetDuration":24,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":24,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Betta Pharmaceuticals Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Oral capsules taken in escalating levels to determine MTD\u002FRP2D. Each treatment cycle will be 21 days in duration with BPI-371153 administered, once daily (QD).",[13],"Drug: BPI-371153",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion","Oral capsules administered at recommended doses. Each treatment cycle will be 21 days in duration with BPI-371153 administered, once daily (QD).\n\nCohort 1: Advanced NSCLC Cohort 2: Relapsed\u002Frefractory lymphoma Cohort 3: Advanced HCC Cohort 4: Other Advanced Solid Tumors",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","BPI-371153","Subjects will receive BPI-371153 until disease progression",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Yuankai Shi, Ph.D","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","010-67781331","syuankaipumc@126.com",[36,45,57,72],{"facility":28,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":24,"geoPoint":24,"contacts":43},"RECRUITING","Chaoyang","Beijing Municipality","100021","China","CN",[44],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":41,"countryCode":42,"cosmosGeoPoint":51,"geoPoint":56,"contacts":24},"Cangzhou Central Hospital","COMPLETED","Cangzhou","Hebei","062650",{"type":52,"coordinates":53},"Point",[54,55],116.85334,38.31124,{"lat":55,"lon":54},{"facility":58,"status":37,"city":59,"state":60,"zip":61,"country":41,"countryCode":42,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Tianjin Cancer Hospital","Tianjin","Tianjin Municipality","300060",{"type":52,"coordinates":63},[64,65],117.17667,39.14222,{"lat":65,"lon":64},[68],{"name":69,"role":32,"phone":70,"phoneExt":24,"email":71},"Xiubao Ren, Ph.D","022-23340123","rwziyi@yahoo.com",{"facility":73,"status":37,"city":59,"state":60,"zip":74,"country":41,"countryCode":42,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Tianjin Medical University General Hospital","300070",{"type":52,"coordinates":76},[64,65],{"lat":65,"lon":64},[79],{"name":80,"role":32,"phone":81,"phoneExt":24,"email":82},"Diansheng Zhong, Ph.D","022-60817009","zhongdsh@hotmail.com",{"type":84,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100465502","phase-1-a-phase-1-study-of-bpi-371153-in-subjects-with-advanced-solid-tumors-or-relapsedrefractory-lymphoma-100465502",false,"NCT05341557","A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed\u002FRefractory Lymphoma","A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed\u002FRefractory Lymphoma","Inclusion Criteria:\n\n* Dose escalation phase: Age ≥18 and ≤65 years, male and female patients; Dose expansion phase: Age ≥18, male and female patients;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;\n* Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients) or relapsed\u002Frefractory lymphoma, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;\n* Dose expansion phase: histologically or cytologically confirmed locally advanced or relapsed\u002Fmetastatic Non-Driver Mutation NSCLC, relapsed\u002Frefractory lymphoma, HCC with Child-Pugh A or B(≤ 7 points), or other diagnosed solid tumor patients who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;\n* Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1( for other diagnosed solid tumos excluding HCC), mRECIST(for HCC) or Lugano 2014(for lymphoma);\n* Adequate organ function;\n\nExclusion Criteria:\n\n* Dose escalation phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)\u002Fprogrammed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy;\n* Dose expansion phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)\u002Fprogrammed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy within 28 days prior to treatment. Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies;\n* Prior other specific T cell targeting agents;\n* Use of systemic or absorbable topical corticosteroids therapy(≥ 10 mg\u002Fday prednisone or equivalent) two weeks prior to start of treatment.\n* Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, and vaccine;\n* Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable\u002Fsymptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;\n* Pregnancy or lactation;\n* Other conditions considered not appropriate to participate in this trial by the investigators.","ALL","18 Years",{"count":95,"type":96},110,"ESTIMATED","INTERVENTIONAL",[99],"PHASE1","A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-371153, a PD-L1 Inhibitor, in patients with advanced solid tumors or relapsed\u002Frefractory lymphoma.",[102,103,104,105],"Advanced Solid Tumor","Lymphoma","NSCLC","HCC","2025-01-22",{"date":108,"type":109},"2025-01-27","ACTUAL",{"date":111,"type":109},"2022-08-29",{"date":113,"type":96},"2027-04",{"name":5,"class":6},4]