[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601207":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":101,"collaborators":25,"id":103,"slug":25,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":25,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":25,"enrollmentInfo":111,"targetDuration":25,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"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",[41,51,62,72,82,91],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":25},"Queen Mary Hospital","RECRUITING","Hong Kong",{"type":46,"coordinates":47},"Point",[48,49],114.17469,22.27832,{"lat":49,"lon":48},{"facility":52,"status":43,"city":53,"state":54,"zip":55,"country":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":25},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577","Japan",{"type":46,"coordinates":58},[59,60],139.97732,35.86224,{"lat":60,"lon":59},{"facility":63,"status":43,"city":64,"state":65,"zip":66,"country":56,"cosmosGeoPoint":67,"geoPoint":71,"contacts":25},"Ehime University Hospital","Tōon","Ehime","791-0295",{"type":46,"coordinates":68},[69,70],132.89011,33.79427,{"lat":70,"lon":69},{"facility":73,"status":43,"city":74,"state":75,"zip":76,"country":56,"cosmosGeoPoint":77,"geoPoint":81,"contacts":25},"Kindai University Hospital","Sakai","Osaka","590-0197",{"type":46,"coordinates":78},[79,80],135.46653,34.58216,{"lat":80,"lon":79},{"facility":83,"status":43,"city":84,"state":25,"zip":85,"country":56,"cosmosGeoPoint":86,"geoPoint":90,"contacts":25},"Niigata Cancer Center Hospital","Niigata","951-8566",{"type":46,"coordinates":87},[88,89],139.04125,37.92259,{"lat":89,"lon":88},{"facility":92,"status":43,"city":93,"state":25,"zip":94,"country":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":25},"Show Chwan Memorial Hospital","Changhua","500","Taiwan",{"type":46,"coordinates":97},[98,99],120.5512,24.0692,{"lat":99,"lon":98},{"type":102,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":112,"type":113},122,"ESTIMATED","INTERVENTIONAL",[116],"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.",[119],"Extensive Stage Small Cell Lung Cancer","2026-02-04",{"date":122,"type":123},"2026-02-06","ACTUAL",{"date":125,"type":123},"2025-10-08",{"date":127,"type":113},"2028-09-30",{"name":5,"class":6},6]