A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)

Summary

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.

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.

Conditions3

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