[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-mutations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-mutations":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100480185","phase-1-phase-1b2-study-to-evaluate-abt-101-in-solid-tumor-and-nsclc-patients-100480185",false,"NCT05532696","Phase 1b\u002F2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ABT-101 in Patients With Advanced Solid Tumors and HER2 Exon 20 Insertions Mutated Non- Small Cell Lung Cancer","Inclusion Criteria:\n\n* Male or female aged ≥ 20 years or adult age as per local regulations, at time of informed consent\n* Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLC with HER2 mutations as determined by the central result (Part 2)\n* For patients in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Part 1), 0 to 2 (Part 2)\n* Appropriate candidate for experimental therapy\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known active or untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs.\n* Serious acute or chronic infections\n* Received a live-virus vaccination\n* Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.\n* Not recovered from prior- treatment toxicities to Grade ≤1\n* Major surgery within 28 days prior to the study treatment\n* Concurrent malignancy within 2 years prior to first dose\n* History or presence of clinically relevant cardiovascular abnormalities. QTcF ≥ 470 ms\n* Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101\n* Known to have a history of alcoholism or drug abuse","ALL","18 Years",{"count":19,"type":20},61,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","A Phase 1b\u002F2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore antitumor activities of ABT-101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)",[27,28,29],"Advanced Solid Tumor","Non Small Cell Lung Cancer","HER2 Mutations",[31,32,29],"ABT-101","NSCLC","RECRUITING","2024-06-21",{"date":36,"type":37},"2024-06-24","ACTUAL",{"date":39,"type":37},"2022-09-27",{"date":41,"type":20},"2027-05",{"name":43,"class":44},"Anbogen Therapeutics, Inc.","INDUSTRY",5]