[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611024":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":47,"centralContacts":58,"locations":64,"responsibleParty":126,"collaborators":47,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":47,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":47,"studyType":141,"phases":142,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":67,"whyStopped":47,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Shenzhen Majory Biotechnology Co., Ltd.","INDUSTRY",[8,15,19,23,29,33,37],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV\u002F5-FU","EXPERIMENTAL","MR001, 2mg\u002Fkg, QW; Irinotecan Liposome+LV\u002F5-FU, Per locally approved dosage and administration",[13,14],"Drug: MR001","Drug: Irinotecan Liposome Injection combined with 5-FU\u002FLV",{"label":16,"type":10,"description":17,"interventionNames":18},"Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV\u002F5-FU","MR001, 4mg\u002Fkg, QW; Irinotecan Liposome+LV\u002F5-FU, Per locally approved dosage and administration",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV\u002F5-FU","MR001, 6mg\u002Fkg, QW; Irinotecan Liposome+LV\u002F5-FU, Per locally approved dosage and administration",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine","MR001, 2mg\u002Fkg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration",[13,27,28],"Drug: Nab-paclitaxel","Drug: Gemcitabine (GEM)",{"label":30,"type":10,"description":31,"interventionNames":32},"Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine","MR001, 4mg\u002Fkg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration",[13,27,28],{"label":34,"type":10,"description":35,"interventionNames":36},"Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine","MR001, 6mg\u002Fkg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration",[13,27,28],{"label":38,"type":10,"description":39,"interventionNames":40},"Dose Expansion Part","Based on the Dose escalation part results, the Investigator and Sponsor will determine one dose and dosing interval to proceed to the dose expansion study",[13,14,27,28],[42,48,52,55],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","MR001","Intravenous infusion",[9,16,20,24,30,34,38],null,{"type":43,"name":49,"description":50,"armGroupLabels":51,"otherNames":47},"Irinotecan Liposome Injection combined with 5-FU\u002FLV","Per locally approved formulation",[9,16,20,38],{"type":43,"name":53,"description":50,"armGroupLabels":54,"otherNames":47},"Nab-paclitaxel",[24,30,34,38],{"type":43,"name":56,"description":50,"armGroupLabels":57,"otherNames":47},"Gemcitabine (GEM)",[24,30,34,38],[59],{"name":60,"role":61,"phone":62,"phoneExt":47,"email":63},"Qingshan Xue","CONTACT","+86 13332895357","xueqs@majory.com.cn",[65,84,95,111],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Beijing Tsinghua Changgung Hospital","RECRUITING","Beijing","Beijing Municipality","102218","China","CN",{"type":74,"coordinates":75},"Point",[76,77],116.39723,39.9075,{"lat":77,"lon":76},[80],{"name":81,"role":61,"phone":82,"phoneExt":47,"email":83},"Jiahong Dong, MD, PhD","+86-10-56118899","dongjiahong@mail.tsinghua.edu.cn",{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":71,"countryCode":72,"cosmosGeoPoint":90,"geoPoint":94,"contacts":47},"Sun Yat-sen Memorial Hospital, Sun Yat-sen University","ACTIVE_NOT_RECRUITING","Guangzhou","Guangdong","510000",{"type":74,"coordinates":91},[92,93],113.25,23.11667,{"lat":93,"lon":92},{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":71,"countryCode":72,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Harbin Medical University Cancer Hospital","NOT_YET_RECRUITING","Harbin","Heilongjiang","150081",{"type":74,"coordinates":102},[103,104],126.65,45.75,{"lat":104,"lon":103},[107],{"name":108,"role":61,"phone":109,"phoneExt":47,"email":110},"Tongsen Zheng, PhD","+86 15134569619","yqbfzhengtongsen@163.com",{"facility":112,"status":97,"city":113,"state":114,"zip":115,"country":71,"countryCode":72,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"The First Hospital of Jilin University","Changchun","Jilin","130015",{"type":74,"coordinates":117},[118,119],125.32278,43.88,{"lat":119,"lon":118},[122],{"name":123,"role":61,"phone":124,"phoneExt":47,"email":125},"Wei Li, PhD","+86 13756661267","jdyylw@163.com",{"type":127,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100611024","phase-1-a-study-of-mr001-combined-with-chemotherapy-in-patients-with-locally-advanced-or-metastatic-pancreatic-ductal-adenocarcinoma-pdac-after-first-line-therapy-100611024",false,"NCT07235202","A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy","An Open-label, Dose-escalation and Dose-expansion Phase Ib\u002FIIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MR001 in Combination With Standard Chemotherapy Regimens in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Who Have Progressed After First-line Therapy","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic PDAC, progressed after only one prior line of systemic therapy.\n* At least one measurable lesion per RECIST v1.1.\n* ECOG Performance Status of 0-1.\n* Life expectancy \\>3 months.\n* Adequate organ and marrow function as defined by laboratory parameters.\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Known hypersensitivity to MR001 or similar monoclonal antibodies.\n* Requirement for systemic immunosuppressive therapy within 14 days before first dosing.\n* Uncontrolled active infections or concurrent malignancies.\n* Not adequately controlled active brain metastases or leptomeningeal metastasis.\n* Clinically significant cardiovascular, renal, or hepatic disorders.\n* Pregnant or breastfeeding women.\n* Any other circumstances which the investigator considers may increase risks to subjects or interfere with the results of the trial.","ALL","18 Years","75 Years",{"count":139,"type":140},45,"ESTIMATED","INTERVENTIONAL",[143,144],"PHASE1","PHASE2","This Phase Ib\u002FIIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 Combined with Chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.",[147],"Pancreatic Ductal Adenocarcinoma (PDAC)",[44,149,150,151],"PDAC","CD4","TGF-β1","2026-05-21",{"date":154,"type":155},"2026-05-26","ACTUAL",{"date":157,"type":155},"2025-12-24",{"date":159,"type":140},"2028-12-22",{"name":5,"class":6},4]