Recruiting

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

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.

ClinicalTrials.gov IDNCT07208149
PhasePHASE1, PHASE2
Enrollment42
SponsorShenzhen Majory Biotechnology Co., Ltd.
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Triple-Negative Breast Cancer (TNBC)

About this study

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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.