Triple-Negative Breast Cancer (TNBC)
Conditions
Brief 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.
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
DRUGMR001 Bispecific Antibody for Injection
Intravenous infusion
Sponsors
Shenzhen Majory Biotechnology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Recommended Phase II Dose (RP2D) based on safety, pharmacodynamics, pharmacokinetics and Preliminary Anti-tumor Activity of MR001 | Approximately 6 months |
| Progression-free survival (PFS) | Approximately 2 years |
| Duration of response (DOR) | Approximately 2 years |
| Overall survival (OS) | Approximately 3 years |
| Objective Response Rate (ORR) | Approximately 2 years |
| Area Under the Plasma Concentration-Time Curve (AUC) of MR001 | Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks) |
| Maximum Plasma Concentration (Cmax) of MR001 | Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks) |
| Time to Maximum Plasma Concentration (Tmax) of MR001 | 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 | Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks) |
| Change from baseline at different timepoints for Th1 of MR001 | Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks) |
| Change from baseline at different timepoints for Th2 of MR001 | Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks) |
| Incidence of Antidrug Antibodies (ADA) to MR001 | Predose in each cycle for approximately 2 years (each cycle = 2 weeks) |
Countries
China
Contacts
CONTACTQingshan Xue
PRINCIPAL_INVESTIGATORBinghe Xu
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed