[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Majory Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Pancreatic Ductal Adenocarcinoma (PDAC)",[30,31,32,33],"MR001","PDAC","CD4","TGF-β1","RECRUITING","2026-05-21",{"date":37,"type":38},"2026-05-26","ACTUAL",{"date":40,"type":38},"2025-12-24",{"date":42,"type":21},"2028-12-22",{"name":44,"class":45},"Shenzhen Majory Biotechnology Co., Ltd.","INDUSTRY",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100608945","phase-1-a-study-of-mr001-in-patients-with-locally-recurrent-or-metastatic-advanced-triple-negative-breast-cancer-tnbc-100608945","NCT07208149","A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)","A Phase Ib\u002FIIa, Open-Label, Two-Cohort, Dose-Escalation and Dose-Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC) Who Have Progressed After First-Line or Later-Line Therapy","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed triple-negative breast cancer (TNBC).\n* Subjects with locally recurrent or metastatic advanced TNBC who have progressed after first-line or later-line therapy.\n* Presence of at least one measurable lesion according to RECIST V1.1 criteria.\n* ECOG Performance Status 0 or 1.\n* Life expectancy \\>3 months.\n* Adequate organ and hematopoietic function based on the laboratory tests.\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* History of severe allergy or hypersensitivity to the investigational product or its excipients or drugs of similar chemical class (e.g., monoclonal antibodies), or contraindications to the investigational product.\n* Requirement for systemic immunosuppressive therapy within 14 days prior to the first dose of study drug or during the study.\n* Major surgery (excluding puncture biopsy) within 4 weeks prior to the first dose of study drug, or anticipated need for major surgery during this study.\n* Uncontrolled active brain metastases or leptomeningeal metastasis.\n* History of autoimmune disease requiring treatment with corticosteroids or immunosuppressive drugs.\n* Women in the period of preconception, pregnancy, or lactation.\n* Any other circumstances which the investigator considers may increase risks to subjects or interfere with the results of the trial.",{"count":55,"type":21},42,[24,25],"This Phase Ib\u002FIIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 in patients with advanced triple-negative breast cancer (TNBC) who have progressed after prior therapy.",[59],"Triple-Negative Breast Cancer (TNBC)","2026-02-09",{"date":62,"type":38},"2026-02-12",{"date":64,"type":38},"2026-01-29",{"date":66,"type":21},"2028-09-01",{"name":44,"class":45},1,""]