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.
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.
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.
Sequential
MR001 Bispecific Antibody for Injection
DrugIntravenous infusion
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Maximum Tolerated Dose (MTD) of MR001
The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0
Recommended Phase II Dose (RP2D) based on safety, pharmacodynamics, pharmacokinetics and Preliminary Anti-tumor Activity of MR001
Progression-free survival (PFS)
Duration of response (DOR)
Overall survival (OS)
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