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)
Number of participants who experience one or more dose-limiting toxicities (DLTs) — Approximately 6 months
Maximum Tolerated Dose (MTD) of MR001 — Approximately 6 months The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0 — Approximately 2 years
Trial sites (1)
Facility
City
Region
Status
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
China
Recruiting
More Shenzhen Majory Biotechnology Co., Ltd. trials in China
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.
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