RecruitingPhase 1Phase 2NCT07208149

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

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


Sponsor

Shenzhen Majory Biotechnology Co., Ltd.

Enrollment

42 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called MR001 for people with triple-negative breast cancer (TNBC) — a type of breast cancer that lacks common hormone and protein receptors, making it harder to treat. The study is for patients whose cancer has spread or come back after previous treatment. **You may be eligible if...** - You have been diagnosed with triple-negative breast cancer confirmed by lab testing - Your cancer has spread (metastatic) or come back locally after first or later lines of treatment - You have at least one measurable tumor on a scan - You are in good general health (ECOG score 0 or 1) - Your life expectancy is more than 3 months - Your liver, kidneys, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have a history of severe allergic reactions to similar types of drugs (like monoclonal antibodies) - You are currently on systemic immunosuppressant medications - You have certain active infections or other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMR001 Bispecific Antibody for Injection

Intravenous infusion


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

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NCT07208149


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