[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522534":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":26,"responsibleParty":44,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Shanghai Chest Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oba01","EXPERIMENTAL",null,[13],"Drug: Oba01",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Oba01 0.15, 0.5, 0.75, 1.0 mg\u002Fkg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"Shun Lu, PhD","CONTACT","86-21-62821990","15216769608","shunlu@sjtu.edu.cn",[27],{"facility":28,"status":29,"city":30,"state":11,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University","RECRUITING","Shanghai","200030","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},[41],{"name":42,"role":22,"phone":43,"phoneExt":11,"email":25},"Shun Lu","86-21-22200000",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Lu Shun","Prof.","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":59,"type":60},35,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA\u002FmNSCLC.",[66],"Non-small Cell Lung Cancer Metastatic","2023-12-14",{"date":69,"type":70},"2023-12-20","ACTUAL",{"date":72,"type":70},"2023-12-13",{"date":74,"type":60},"2026-07",{"name":46,"class":6},1]