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

Shenzhen Majory Biotechnology Co., Ltd.

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Triple-Negative Breast Cancer (TNBC)

Treatments: Drug: MR001 Bispecific Antibody for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07208149

MJR-MR001-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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42 participants in 5 patient groups

Dose Escalation Part, Dose Group A: MR001 1 mg/kg, QW

Experimental group

Treatment:

Drug: MR001 Bispecific Antibody for Injection

Dose Escalation Part, Dose Group B: MR001 2 mg/kg, QW

Experimental group

Treatment:

Drug: MR001 Bispecific Antibody for Injection

Dose Escalation Part, Dose Group C: MR001 4 mg/kg, QW

Experimental group

Treatment:

Drug: MR001 Bispecific Antibody for Injection

Dose Escalation Part, Dose Group D: MR001 2 mg/kg, Q2W

Experimental group

Treatment:

Drug: MR001 Bispecific Antibody for Injection

Dose Expansion Part

Experimental group

Description:

Based on the Dose escalation part results, the Investigator and Sponsor will determine one dose and dosing interval to proceed to the dose expansion study

Treatment:

Drug: MR001 Bispecific Antibody for Injection