[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601207":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":104,"collaborators":25,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":25,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":25,"enrollmentInfo":115,"targetDuration":25,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Chugai Pharmaceutical","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation part","EXPERIMENTAL","Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to determine the MTD by evaluating DLTs in patients with extensive stage small cell lung cancer.",[13,14],"Drug: ALPS12","Drug: obinutuzumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Expansion part","Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ALPS12","ALPS12 as an IV infusion",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"obinutuzumab","Obinutuzumab as an IV infusion",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Sponsor Chugai Pharmaceutical Co.Ltd","clinical-trials@chugai-pharm.co.jp","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":33},"Clinical trials information","CONTACT","only use Email",[41,52,64,74,84,93],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"Queen Mary Hospital","RECRUITING","Hong Kong","HK",{"type":47,"coordinates":48},"Point",[49,50],114.17469,22.27832,{"lat":50,"lon":49},{"facility":53,"status":43,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":25},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577","Japan","JP",{"type":47,"coordinates":60},[61,62],139.97732,35.86224,{"lat":62,"lon":61},{"facility":65,"status":43,"city":66,"state":67,"zip":68,"country":57,"countryCode":58,"cosmosGeoPoint":69,"geoPoint":73,"contacts":25},"Ehime University Hospital","Tōon","Ehime","791-0295",{"type":47,"coordinates":70},[71,72],132.89011,33.79427,{"lat":72,"lon":71},{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":57,"countryCode":58,"cosmosGeoPoint":79,"geoPoint":83,"contacts":25},"Kindai University Hospital","Sakai","Osaka","590-0197",{"type":47,"coordinates":80},[81,82],135.46653,34.58216,{"lat":82,"lon":81},{"facility":85,"status":43,"city":86,"state":25,"zip":87,"country":57,"countryCode":58,"cosmosGeoPoint":88,"geoPoint":92,"contacts":25},"Niigata Cancer Center Hospital","Niigata","951-8566",{"type":47,"coordinates":89},[90,91],139.04125,37.92259,{"lat":91,"lon":90},{"facility":94,"status":43,"city":95,"state":25,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":25},"Show Chwan Memorial Hospital","Changhua","500","Taiwan","TW",{"type":47,"coordinates":100},[101,102],120.5512,24.0692,{"lat":102,"lon":101},{"type":105,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100601207","phase-1-a-phase-i-study-of-alps12-in-patients-with-extensive-stage-small-cell-lung-cancer-100601207",false,"NCT07107490","A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Aged \\>18 years at time of informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Histologically documented extensive stage small cell lung cancer\n* Disease recurrence documented after at least one prior systemic therapy.\n* Confirmed availability of representative archival tumor specimens or fresh tumor specimen.\n* Measurable disease per RECIST v.1.1.\n* Adequate hematologic and end organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study\n* History or complication of clinically significant autoimmune disease\n* a positive HIV antibody test at screening\n* Active hepatitis B or hepatitis C\n* Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and\u002For DLL3-targeted therapies\n* Patients who have received any investigational or approved anticancer therapy, including hormone therapy and\u002For radiotherapy, within 21 days prior to the first administration of the investigational drug.\n* History of Grade 4 immune-related adverse events caused by prior anti-PD-L1\u002FPD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase\u002Flipase)\n* Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1\u002FPD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase\u002Flipase), and\u002For patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug\n* Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug\n* History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease\n* Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)","ALL","18 Years",{"count":116,"type":117},122,"ESTIMATED","INTERVENTIONAL",[120],"PHASE1","This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.",[123],"Extensive Stage Small Cell Lung Cancer","2026-02-04",{"date":126,"type":127},"2026-02-06","ACTUAL",{"date":129,"type":127},"2025-10-08",{"date":131,"type":117},"2028-09-30",{"name":5,"class":6},6]