[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519664":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":11,"armGroups":42,"interventions":49,"overallOfficials":11,"centralContacts":54,"locations":60,"responsibleParty":137,"collaborators":11,"id":139,"slug":11,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":11,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":11,"enrollmentInfo":147,"targetDuration":11,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Avistone Biotechnology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Safety profile of PLB1004 per CTCAE v5.0",null,"Up to 2 years",[14,17,20,22,24,26,28,30,32,34],{"measure":15,"description":11,"timeFrame":16},"To define the DLTs and MTD","Up to 3 years",{"measure":18,"description":11,"timeFrame":19},"Area Under the Curve (AUC) of PLB1004","Approximately 28 days.",{"measure":21,"description":11,"timeFrame":19},"Maximum plasma concentration (Cmax) of PLB1004",{"measure":23,"description":11,"timeFrame":19},"Time to maximum plasma concentration (Tmax) of PLB1004",{"measure":25,"description":11,"timeFrame":16},"Overall Response Rate (ORR)",{"measure":27,"description":11,"timeFrame":16},"Progression-Free Survival (PFS)",{"measure":29,"description":11,"timeFrame":16},"Overall Survival (OS)",{"measure":31,"description":11,"timeFrame":16},"Disease Control Rate (DCR)",{"measure":33,"description":11,"timeFrame":16},"Duration of Response (DOR)",{"measure":35,"description":11,"timeFrame":16},"Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"NA","SEQUENTIAL","TREATMENT",{"masking":41,"maskingDescription":11,"whoMasked":11},"NONE",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"PLB1004","EXPERIMENTAL","PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.",[48],"Drug: PLB1004",[50],{"type":51,"name":44,"description":52,"armGroupLabels":53,"otherNames":11},"DRUG","PLB1004 will be orally self-administered by the patient as a mono-therapy.",[44],[55],{"name":56,"role":57,"phone":58,"phoneExt":11,"email":59},"Avistone Clinical Study Information Center Center","CONTACT","+86-10-84148921","information.center@avistonebio.com",[61,78,88,100,108,120,132],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"University of California-Davis","RECRUITING","Sacramento","California","95817-1514","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-121.4944,38.58157,{"lat":73,"lon":72},[76],{"name":77,"role":57,"phone":11,"phoneExt":11,"email":11},"Study Director, MD",{"facility":79,"status":63,"city":80,"state":81,"zip":82,"country":67,"countryCode":68,"cosmosGeoPoint":83,"geoPoint":87,"contacts":11},"Research Site","Louisville","Kentucky","40202",{"type":70,"coordinates":84},[85,86],-85.75941,38.25424,{"lat":86,"lon":85},{"facility":89,"status":63,"city":90,"state":91,"zip":92,"country":67,"countryCode":68,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Nebraska Cancer Specialists","Omaha","Nebraska","68130",{"type":70,"coordinates":94},[95,96],-95.94043,41.25626,{"lat":96,"lon":95},[99],{"name":77,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":79,"status":63,"city":101,"state":101,"zip":102,"country":67,"countryCode":68,"cosmosGeoPoint":103,"geoPoint":107,"contacts":11},"New York","100021",{"type":70,"coordinates":104},[105,106],-74.00597,40.71427,{"lat":106,"lon":105},{"facility":109,"status":63,"city":110,"state":111,"zip":112,"country":67,"countryCode":68,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"type":70,"coordinates":114},[115,116],-86.78444,36.16589,{"lat":116,"lon":115},[119],{"name":77,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":121,"status":63,"city":122,"state":123,"zip":124,"country":67,"countryCode":68,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Swedish Health Sciences","Seattle","Washington","98122",{"type":70,"coordinates":126},[127,128],-122.33207,47.60621,{"lat":128,"lon":127},[131],{"name":77,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":79,"status":63,"city":122,"state":123,"zip":133,"country":67,"countryCode":68,"cosmosGeoPoint":134,"geoPoint":136,"contacts":11},"98195",{"type":70,"coordinates":135},[127,128],{"lat":128,"lon":127},{"type":138,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100519664",false,"NCT06046495","A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer","A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document;\n2. Male or female adult patients 18 years of age or older;\n3. Patients should have recovered from toxicities related to prior anti-tumor therapy;\n4. Patients should have recovered from the effects of major surgery;\n5. Have a documented EGFR mutation by a local test in tissue or plasma;\n6. At least 12 weeks life expectancy;\n7. Must have at least one measurable lesion per RECIST v 1.1;\n8. Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Received radiotherapy within 14 days before enrollment;\n2. Have significant or uncontrolled systemic disease;\n3. Have significant or uncontrolled cardiovascular disease;\n4. Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;\n5. Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;\n6. Have known hypersensitivity to the similar drugs and excipients of PLB1004;\n7. Pregnant or lactating women;\n8. Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;\n9. Have any condition or illness that could affect the compliance with the protocol.","ALL","18 Years",{"count":148,"type":149},81,"ESTIMATED","INTERVENTIONAL",[152],"PHASE1","This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.",[155],"Non-Small Cell Lung Cancer","2025-04-21",{"date":158,"type":159},"2025-04-23","ACTUAL",{"date":161,"type":159},"2024-07-08",{"date":163,"type":149},"2028-02-09",{"name":5,"class":6},7]