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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-29

Study Completion Date

2028-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Triple-Negative Breast Cancer (TNBC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

MR001 Bispecific Antibody for Injection

Intervention Type DRUG

Intravenous infusion

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

Group Type EXPERIMENTAL

MR001 Bispecific Antibody for Injection

Intervention Type DRUG

Intravenous infusion

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

Group Type EXPERIMENTAL

MR001 Bispecific Antibody for Injection

Intervention Type DRUG

Intravenous infusion

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

Group Type EXPERIMENTAL

MR001 Bispecific Antibody for Injection

Intervention Type DRUG

Intravenous infusion

Dose Expansion Part

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

Group Type EXPERIMENTAL

MR001 Bispecific Antibody for Injection

Intervention Type DRUG

Intravenous infusion

Interventions

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MR001 Bispecific Antibody for Injection

Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No