Overview
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.
Description
This is a dual-cohort, open-label, dose escalation and dose expansion Phase Ib/IIa 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.
Eligibility
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.