A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Recruiting · NCT07208149 · Interventional (participants receive a specific treatment) · Lead sponsor: Shenzhen Majory Biotechnology Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
MR001 Bispecific Antibody for Injection
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
- Uncontrolled active brain metastases or leptomeningeal metastasis.
- History of autoimmune disease requiring treatment with corticosteroids or immunosuppressive drugs.
- 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.
Where it is running
1 location listed.
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing, China