NCT07208149RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
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
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 19 Sept 2025
- Start date
- 29 Jan 2026
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Shenzhen Majory Biotechnology Co., Ltd.
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07208149
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 42
- From 29 Jan 2026 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.