Actively Recruiting
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Led by Shenzhen Majory Biotechnology Co., Ltd. · Updated on 2026-02-12
42
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed triple-negative breast cancer (TNBC).
- Locally recurrent or metastatic advanced TNBC that has progressed after first-line or later-line therapy.
- At least one measurable lesion according to RECIST V1.1 criteria.
- ECOG Performance Status of 0 or 1.
- Life expectancy greater than 3 months.
- Adequate organ and hematopoietic function based on laboratory tests.
- Signed informed consent form voluntarily.
You will not qualify if you...
- History of severe allergy or hypersensitivity to the investigational product, similar monoclonal antibodies, or its excipients.
- Need for systemic immunosuppressive therapy within 14 days before first dose or during the study.
- Major surgery (excluding puncture biopsy) within 4 weeks before first dose or planned during the study.
- Uncontrolled active brain metastases or leptomeningeal metastasis.
- History of autoimmune disease requiring corticosteroids or immunosuppressive drugs.
- Women who are pregnant, breastfeeding, or planning pregnancy.
- Any other condition the investigator considers may increase risk or affect study results.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
Q
Qingshan Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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