[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595323":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":39,"locations":44,"responsibleParty":86,"collaborators":29,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":29,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":29,"enrollmentInfo":97,"targetDuration":29,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":29,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Chugai Pharmaceutical","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Dose Escalation part of AUBE00 monotherapy","EXPERIMENTAL","Patients will receive AUBE00 as an oral administration at escalated doses.",[13],"Drug: AUBE00",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B: Expansion part of AUBE00 monotherapy","Patients will receive AUBE00 as an oral administration at multiple dose levels determined to be safe (including MTD).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab","Patients will receive AUBE00 as an oral administration in combination with cetuximab as an IV infusion at escalated doses or the recommended dose level.",[13,22],"Drug: Cetuximab",[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","AUBE00","AUBE00 as an oral administration",[9,15,19],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Cetuximab","Cetuximab as an IV infusion",[19],[35],{"name":36,"affiliation":37,"role":38},"Sponsor Chugai Pharmaceutical Co.Ltd","clinical-trials@chugai-pharm.co.jp","STUDY_DIRECTOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":29,"email":37},"Clinical trials information","CONTACT","only use Email",[45,59,69,81],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":29},"South Texas Accelerated Research Therapeutics (START) Midwest","RECRUITING","Grand Rapids","Michigan","49546","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-85.66809,42.96336,{"lat":57,"lon":56},{"facility":60,"status":47,"city":61,"state":62,"zip":63,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":68,"contacts":29},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":54,"coordinates":65},[66,67],-95.36327,29.76328,{"lat":67,"lon":66},{"facility":70,"status":47,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":29},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577","Japan","JP",{"type":54,"coordinates":77},[78,79],139.97732,35.86224,{"lat":79,"lon":78},{"facility":82,"status":47,"city":83,"state":84,"zip":85,"country":74,"countryCode":75,"cosmosGeoPoint":29,"geoPoint":29,"contacts":29},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045",{"type":87,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100595323","phase-1-study-of-aube00-in-patients-with-solid-tumors-100595323",false,"NCT07030959","Study of AUBE00 in Patients With Solid Tumors","A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years at time of signing Informed Consent Form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patients with Kirsten rat sarcoma (KRAS) alteration confirmed by local tests or central laboratory test (Details are defined for each part)\n* Refractory or resistant to standard therapies or standard therapies are not available\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study or within 27 weeks after the last dose of AUBE00 or within 2 months after the last dose of cetuximab, whichever is longer.\n* Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)\n* Significant cardiovascular disease, such as New York Heart Association (NYHA) Class II or greater cardiac disease, unstable angina, or myocardial infraction within the previous 6 months or unstable arrhythmias within the previous 3 months\n* Patient with complications from a cerebrovascular disorder (such as subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, etc.) or a history of such complications within 6 months prior to enrollment","ALL","18 Years",{"count":98,"type":99},130,"ESTIMATED","INTERVENTIONAL",[102],"PHASE1","This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors.The total number of patients in this study will be approximately 90 to 130.",[105],"Solid Tumors","2026-02-23",{"date":108,"type":109},"2026-02-25","ACTUAL",{"date":111,"type":109},"2025-06-05",{"date":113,"type":99},"2029-12-31",{"name":5,"class":6},4]