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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Patients with diagnosed by tissue sample (biopsy-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. - You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. - Life expectancy \>3 months. - Adequate organ and hematopoietic function based on the laboratory tests. - Voluntarily sign the willing to sign a consent form form. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body) 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

MR001 Bispecific Antibody for Injection

Intravenous infusion

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China