A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат MR001 Bispecific Antibody for Injection
  Intravenous infusion

Первичные конечные точки

• Number of participants who experience one or more dose-limiting toxicities (DLTs) [Срок оценки: Approximately 6 months]
• Maximum Tolerated Dose (MTD) of MR001 [Срок оценки: Approximately 6 months]
• Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0 [Срок оценки: Approximately 2 years]

Вторичные конечные точки (12)

• Recommended Phase II Dose (RP2D) based on safety, pharmacodynamics, pharmacokinetics and Preliminary Anti-tumor Activity of MR001 [Срок оценки: Approximately 6 months]
• Progression-free survival (PFS) [Срок оценки: Approximately 2 years]
• Duration of response (DOR) [Срок оценки: Approximately 2 years]
• Overall survival (OS) [Срок оценки: Approximately 3 years]
• Objective Response Rate (ORR) [Срок оценки: Approximately 2 years]
• Area Under the Plasma Concentration-Time Curve (AUC) of MR001 [Срок оценки: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)]
• Maximum Plasma Concentration (Cmax) of MR001 [Срок оценки: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)]
• Time to Maximum Plasma Concentration (Tmax) of MR001 [Срок оценки: 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 [Срок оценки: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)]
• Change from baseline at different timepoints for Th1 of MR001 [Срок оценки: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)]
• Change from baseline at different timepoints for Th2 of MR001 [Срок оценки: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)]
• Incidence of Antidrug Antibodies (ADA) to MR001 [Срок оценки: Predose in each cycle for approximately 2 years (each cycle = 2 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07208149 · MJR-MR001-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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