MR001 treatment for locally recurrent or metastatic triple-negative breast cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib/IIa, open-label, dual-cohort study includes a dose-escalation phase followed by dose-expansion to test MR001 in patients with locally recurrent or metastatic TNBC who have progressed after first-line or later therapy. The trial will collect safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity data using RECIST v1.1 measurable disease criteria. Eligible patients must have histologically confirmed TNBC, an ECOG performance status of 0–1, adequate organ function, and a life expectancy over three months. The study is conducted at Cancer Hospital Chinese Academy of Medical Sciences in Beijing and uses regular clinic visits and imaging to monitor response and adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Hubei, China Not yet recruiting
• Hunan Cancer Hospital
  Hunan, China Not yet recruiting

Study contacts

• Principal investigator: Binghe Xu — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Qingshan Xue
• Email: xueqs@majory.com.cn
• Phone: +86 13332895357

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.