[{"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:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100522534","phase-1-an-early-stage-study-to-evaluate-oba01-for-injection-in-patients-with-dr5-positive-lamnsclc-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":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA\u002FmNSCLC.",[27],"Non-small Cell Lung Cancer Metastatic","RECRUITING","2023-12-14",{"date":31,"type":32},"2023-12-20","ACTUAL",{"date":34,"type":32},"2023-12-13",{"date":36,"type":21},"2026-07",{"name":38,"class":39},"Lu Shun","OTHER",""]