A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MR001 Bispecific Antibody for Injection.
- Who it may be relevant to
- Registry conditions: Triple-Negative Breast Cancer (TNBC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
This is a dual-cohort, open-label, dose escalation and dose expansion Phase Ib/IIa 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.
Interventions
- Drug MR001 Bispecific Antibody for Injection
Intravenous infusion
Primary outcome measures
- Number of participants who experience one or more dose-limiting toxicities (DLTs) [Time frame: Approximately 6 months]
- Maximum Tolerated Dose (MTD) of MR001 [Time frame: Approximately 6 months]
- Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0 [Time frame: Approximately 2 years]
Secondary outcome measures (12)
- Recommended Phase II Dose (RP2D) based on safety, pharmacodynamics, pharmacokinetics and Preliminary Anti-tumor Activity of MR001 [Time frame: Approximately 6 months]
- Progression-free survival (PFS) [Time frame: Approximately 2 years]
- Duration of response (DOR) [Time frame: Approximately 2 years]
- Overall survival (OS) [Time frame: Approximately 3 years]
- Objective Response Rate (ORR) [Time frame: Approximately 2 years]
- Area Under the Plasma Concentration-Time Curve (AUC) of MR001 [Time frame: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)]
- Maximum Plasma Concentration (Cmax) of MR001 [Time frame: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)]
- Time to Maximum Plasma Concentration (Tmax) of MR001 [Time frame: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)]
- Change from baseline at different time points for TGF-β1 in plasma [Time frame: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)]
- Change from baseline at different timepoints for Th1 of MR001 [Time frame: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)]
- Change from baseline at different timepoints for Th2 of MR001 [Time frame: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)]
- Incidence of Antidrug Antibodies (ADA) to MR001 [Time frame: Predose in each cycle for approximately 2 years (each cycle = 2 weeks)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07208149 · MJR-MR001-03