[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608945":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":11,"id":63,"slug":11,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Shenzhen Majory Biotechnology Co., Ltd.","INDUSTRY",[8,14,17,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Part, Dose Group A: MR001 1 mg\u002Fkg, QW","EXPERIMENTAL",null,[13],"Drug: MR001 Bispecific Antibody for Injection",{"label":15,"type":10,"description":11,"interventionNames":16},"Dose Escalation Part, Dose Group B: MR001 2 mg\u002Fkg, QW",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Dose Escalation Part, Dose Group C: MR001 4 mg\u002Fkg, QW",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Dose Escalation Part, Dose Group D: MR001 2 mg\u002Fkg, Q2W",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"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],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DRUG","MR001 Bispecific Antibody for Injection","Intravenous infusion",[9,15,18,21,24],[34],{"name":35,"affiliation":36,"role":37},"Binghe Xu","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":11,"email":43},"Qingshan Xue","CONTACT","+86 13332895357","xueqs@majory.com.cn",[45],{"facility":46,"status":47,"city":48,"state":11,"zip":11,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Cancer Hospital Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58],{"name":35,"role":41,"phone":59,"phoneExt":11,"email":60},"+86-10-87788826","xubinghe@medmail.com.cn",{"type":62,"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":73,"type":74},42,"ESTIMATED","INTERVENTIONAL",[77,78],"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.",[81],"Triple-Negative Breast Cancer (TNBC)","2026-02-09",{"date":84,"type":85},"2026-02-12","ACTUAL",{"date":87,"type":85},"2026-01-29",{"date":89,"type":74},"2028-09-01",{"name":5,"class":6},1]