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RecruitingPhase 1Phase 2NCT07208149

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

Sponsor

Shenzhen Majory Biotechnology Co., Ltd.

Enrollment

42 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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.

Interventions

DRUGMR001 Bispecific Antibody for Injection

Intravenous infusion

Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

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NCT07208149