[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635925":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":19,"id":47,"slug":19,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IBI115","EXPERIMENTAL","Subjects will receive IBI115 therapy until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of treatment with IBI115 is 24M.",[13],"Drug: IBI115",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","IBI115 will be administered. The Dose Limiting Toxicity (DLT) observation period will last for 28 or 21 days after first dose. After completion of the DLT observation period, subject will continue to receive IBI115 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal od consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Xiao Zhang","CONTACT","+86 021 3183 7200","kobe.zhang@innoventbio.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"the second affiliated hospital of AMU","RECRUITING","Chongqing","Chongqing Municipality","400037","China",{"type":35,"coordinates":36},"Point",[37,38],106.55771,29.56026,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":44},"Bo Zhu","+86 023 6875 5114","bozhu_oncology@163.com",{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100635925",false,"NCT07559019","Safety and Preliminary Activity of BI115 in Advanced SCLC","Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants With Advanced Small Cell Lung Cancer","Inclusion Criteria：\n\n1. Participants must be able to understand and sign the written informed consent form for participation in this trial, including all evaluations and procedures specified in this protocol.\n2. Male or female participants aged ≥18 years and ≤75 years.\n3. Participants with histologically or cytologically confirmed advanced small cell lung cancer.\n4. At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n6. Expected survival period ≥12 weeks.\n7. Adequate bone marrow and organ function confirmed during the screening period.\n\nExclusion Criteria：\n\n1. Concurrent participation in another interventional clinical study, except for observational non-interventional studies or being in the survival follow-up phase of an interventional study.\n2. Administration of a live vaccine within 4 weeks prior to the first dose of the study drug or a cancer vaccine within 3 months prior, or planning to receive any live vaccine during the study period.\n3. Adverse reactions from prior anti-tumor therapy that have not resolved to CTCAE v6.0 Grade 0, Grade 1, or baseline levels by the time of the first dose of the study drug.\n4. Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.","ALL","18 Years","75 Years",{"count":57,"type":58},150,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","This study is a multi-regional, open-label phase I study to evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants with Advanced Small Cell Lung Cancer",[64],"Small Cell Lung Cancer (SCLC)","2026-06-02",{"date":67,"type":68},"2026-06-04","ACTUAL",{"date":70,"type":68},"2026-05-21",{"date":72,"type":58},"2030-03-30",{"name":5,"class":6},1]