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
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
- Drug: MR001 Bispecific Antibody for Injection — Intravenous infusion
Primary outcomes
- Number of participants who experience one or more dose-limiting toxicities (DLTs) (Approximately 6 months)
- Maximum Tolerated Dose (MTD) of MR001 (Approximately 6 months)
- Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0 (Approximately 2 years)
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
- Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China
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.