[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519664":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":103,"collaborators":19,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":19,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":19,"enrollmentInfo":114,"targetDuration":19,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Avistone Biotechnology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PLB1004","EXPERIMENTAL","PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.",[13],"Drug: PLB1004",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","PLB1004 will be orally self-administered by the patient as a mono-therapy.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Avistone Clinical Study Information Center Center","CONTACT","+86-10-84148921","information.center@avistonebio.com",[27,44,54,66,74,86,98],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"University of California-Davis","RECRUITING","Sacramento","California","95817-1514","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-121.4944,38.58157,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":19,"phoneExt":19,"email":19},"Study Director, MD",{"facility":45,"status":29,"city":46,"state":47,"zip":48,"country":33,"countryCode":34,"cosmosGeoPoint":49,"geoPoint":53,"contacts":19},"Research Site","Louisville","Kentucky","40202",{"type":36,"coordinates":50},[51,52],-85.75941,38.25424,{"lat":52,"lon":51},{"facility":55,"status":29,"city":56,"state":57,"zip":58,"country":33,"countryCode":34,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Nebraska Cancer Specialists","Omaha","Nebraska","68130",{"type":36,"coordinates":60},[61,62],-95.94043,41.25626,{"lat":62,"lon":61},[65],{"name":43,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":45,"status":29,"city":67,"state":67,"zip":68,"country":33,"countryCode":34,"cosmosGeoPoint":69,"geoPoint":73,"contacts":19},"New York","100021",{"type":36,"coordinates":70},[71,72],-74.00597,40.71427,{"lat":72,"lon":71},{"facility":75,"status":29,"city":76,"state":77,"zip":78,"country":33,"countryCode":34,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"type":36,"coordinates":80},[81,82],-86.78444,36.16589,{"lat":82,"lon":81},[85],{"name":43,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":87,"status":29,"city":88,"state":89,"zip":90,"country":33,"countryCode":34,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Swedish Health Sciences","Seattle","Washington","98122",{"type":36,"coordinates":92},[93,94],-122.33207,47.60621,{"lat":94,"lon":93},[97],{"name":43,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":45,"status":29,"city":88,"state":89,"zip":99,"country":33,"countryCode":34,"cosmosGeoPoint":100,"geoPoint":102,"contacts":19},"98195",{"type":36,"coordinates":101},[93,94],{"lat":94,"lon":93},{"type":104,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100519664","phase-1-a-study-of-the-oral-egfr-inhibitor-plb1004-in-non-small-cell-lung-cancer-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":115,"type":116},81,"ESTIMATED","INTERVENTIONAL",[119],"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.",[122],"Non-Small Cell Lung Cancer","2025-04-21",{"date":125,"type":126},"2025-04-23","ACTUAL",{"date":128,"type":126},"2024-07-08",{"date":130,"type":116},"2028-02-09",{"name":5,"class":6},7]