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Clinical Trials in China / NCT07208149
Recruiting Phase 1/2

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

NCT07208149 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Majory Biotechnology Co., Ltd.
Phase
Phase 1/2
Started
2026-01-29
Last updated
2026-02-12

Condition(s) studied

Triple-Negative Breast Cancer (TNBC)

Investigational drug(s) / intervention(s)

MR001 Bispecific Antibody for Injection

MR001 Bispecific Antibody for Injection: Intravenous infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Hospital Chinese Academy of Medical Sciences Beijing China Recruiting

More Shenzhen Majory Biotechnology Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07208149 on ClinicalTrials.gov ↗ ← All trials in China