[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lu Shun\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100522534",false,"NCT06083870","An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA\u002FmNSCLC","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA\u002FmNSCLC","Inclusion Criteria:\n\n* Voluntary agreement to provide written informed consent.\n* Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment.\n* Histologically and\u002For cytologically-confirmed locally advanced or metastatic NSCLC.\n* Measurable lesion according to RECIST 1.1.\n* Progression after systemic treatment for advanced NSCLC.\n* Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Measurable and\u002For non-measurable disease as per RECIST 1.1 criteria.\n* Adequate organ function as assessed by laboratory tests.\n* Male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during the study and for 6 months after the last day of treatment.\n\nExclusion Criteria:\n\n* Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate.\n* Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment.\n* Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA \\> ULN.\n* Pregnancy, lactation, or breastfeeding.","ALL","18 Years","75 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA\u002FmNSCLC.",[26],"Non-small Cell Lung Cancer Metastatic","RECRUITING","2023-12-14",{"date":30,"type":31},"2023-12-20","ACTUAL",{"date":33,"type":31},"2023-12-13",{"date":35,"type":20},"2026-07",{"name":37,"class":38},"Lu Shun","OTHER",""]