[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608945":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":54,"studyPopulation":11,"armGroups":55,"interventions":74,"overallOfficials":80,"centralContacts":85,"locations":91,"responsibleParty":108,"collaborators":11,"id":110,"slug":11,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":11,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":11,"studyType":122,"phases":123,"briefSummary":126,"conditions":127,"keywords":11,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Shenzhen Majory Biotechnology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Number of participants who experience one or more dose-limiting toxicities (DLTs)",null,"Approximately 6 months",{"measure":14,"description":15,"timeFrame":12},"Maximum Tolerated Dose (MTD) of MR001","The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules",{"measure":17,"description":11,"timeFrame":18},"Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0","Approximately 2 years",[20,22,24,26,29,31,34,36,38,41,43,45],{"measure":21,"description":11,"timeFrame":12},"Recommended Phase II Dose (RP2D) based on safety, pharmacodynamics, pharmacokinetics and Preliminary Anti-tumor Activity of MR001",{"measure":23,"description":11,"timeFrame":18},"Progression-free survival (PFS)",{"measure":25,"description":11,"timeFrame":18},"Duration of response (DOR)",{"measure":27,"description":11,"timeFrame":28},"Overall survival (OS)","Approximately 3 years",{"measure":30,"description":11,"timeFrame":18},"Objective Response Rate (ORR)",{"measure":32,"description":11,"timeFrame":33},"Area Under the Plasma Concentration-Time Curve (AUC) of MR001","Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)",{"measure":35,"description":11,"timeFrame":33},"Maximum Plasma Concentration (Cmax) of MR001",{"measure":37,"description":11,"timeFrame":33},"Time to Maximum Plasma Concentration (Tmax) of MR001",{"measure":39,"description":11,"timeFrame":40},"Change from baseline at different time points for TGF-β1 in plasma","Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)",{"measure":42,"description":11,"timeFrame":40},"Change from baseline at different timepoints for Th1 of MR001",{"measure":44,"description":11,"timeFrame":40},"Change from baseline at different timepoints for Th2 of MR001",{"measure":46,"description":11,"timeFrame":47},"Incidence of Antidrug Antibodies (ADA) to MR001","Predose in each cycle for approximately 2 years (each cycle = 2 weeks)",{"allocation":49,"interventionModel":50,"interventionModelDescription":11,"primaryPurpose":51,"observationalModel":11,"timePerspective":11,"maskingInfo":52},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":53,"maskingDescription":11,"whoMasked":11},"NONE","This is a dual-cohort, open-label, dose escalation and dose expansion Phase Ib\u002FIIa 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.",[56,61,64,67,70],{"label":57,"type":58,"description":11,"interventionNames":59},"Dose Escalation Part, Dose Group A: MR001 1 mg\u002Fkg, QW","EXPERIMENTAL",[60],"Drug: MR001 Bispecific Antibody for Injection",{"label":62,"type":58,"description":11,"interventionNames":63},"Dose Escalation Part, Dose Group B: MR001 2 mg\u002Fkg, QW",[60],{"label":65,"type":58,"description":11,"interventionNames":66},"Dose Escalation Part, Dose Group C: MR001 4 mg\u002Fkg, QW",[60],{"label":68,"type":58,"description":11,"interventionNames":69},"Dose Escalation Part, Dose Group D: MR001 2 mg\u002Fkg, Q2W",[60],{"label":71,"type":58,"description":72,"interventionNames":73},"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",[60],[75],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":11},"DRUG","MR001 Bispecific Antibody for Injection","Intravenous infusion",[57,62,65,68,71],[81],{"name":82,"affiliation":83,"role":84},"Binghe Xu","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[86],{"name":87,"role":88,"phone":89,"phoneExt":11,"email":90},"Qingshan Xue","CONTACT","+86 13332895357","xueqs@majory.com.cn",[92],{"facility":93,"status":94,"city":95,"state":11,"zip":11,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Cancer Hospital Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":99,"coordinates":100},"Point",[101,102],116.39723,39.9075,{"lat":102,"lon":101},[105],{"name":82,"role":88,"phone":106,"phoneExt":11,"email":107},"+86-10-87788826","xubinghe@medmail.com.cn",{"type":109,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100608945",false,"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.","ALL","18 Years","75 Years",{"count":120,"type":121},42,"ESTIMATED","INTERVENTIONAL",[124,125],"PHASE1","PHASE2","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.",[128],"Triple-Negative Breast Cancer (TNBC)","2026-02-09",{"date":131,"type":132},"2026-02-12","ACTUAL",{"date":134,"type":132},"2026-01-29",{"date":136,"type":121},"2028-09-01",{"name":5,"class":6},1]