Tests MR001 in adults with advanced triple-negative breast cancer
Tests MR001 in adults with advanced triple-negative breast cancer that worsened.
Plain-language title generated from the registry record
Registry title: A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Key facts
- Where
- Beijing, Hubei, and Hunan, ChinaSee the 3 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07208149, who can take part
Where in China
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyHubei, ChinaNot yet recruiting
- Hunan Cancer HospitalHunan, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Majory Biotechnology Co., Ltd.
- Trial code
- NCT07208149
- Record updated
- 6 November 2026
- Original description
This Phase Ib/IIa 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.Read full original descriptionShow less
A Phase Ib/IIa, 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
This Phase Ib/IIa 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.
Inclusion: Patients with histologically or cytologically confirmed triple-negative breast cancer (TNBC); Subjects with locally recurrent or metastatic advanced TNBC who have progressed after first-line or later-line therapy; Presence of at least one measurable lesion according to RECIST V1.1 criteria; ECOG Performance Status 0 or 1; Life expectancy >3 months; Adequate organ and hematopoietic function based on the laboratory tests; Voluntarily sign the informed consent form.
Exclusion: 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; Requirement for systemic immunosuppressive therapy within 14 days prior to the first dose of study drug or during the study; 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; History of autoimmune disease requiring treatment with corticosteroids or immunosuppressive drugs; Uncontrolled active brain metastases or leptomeningeal metastasis; Women in the period of preconception, pregnancy, or lactation; Any other circumstances which the investigator considers may increase risks to subjects or interfere with the results of the trial.