NCT07208149 A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
| NCT ID | NCT07208149 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Majory Biotechnology Co., Ltd. |
| Condition | Triple-Negative Breast Cancer (TNBC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-01-29 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Binghe Xu
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT07208149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Triple-Negative Breast Cancer (TNBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07208149 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07208149 currently recruiting?
Yes, NCT07208149 is actively recruiting participants. Contact the research team at xueqs@majory.com.cn for enrollment information.
Where is the NCT07208149 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07208149 clinical trial?
NCT07208149 is sponsored by Shenzhen Majory Biotechnology Co., Ltd.. The principal investigator is Binghe Xu at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 42 participants.
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