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New hope for Hard-to-Treat breast cancer: experimental drug MR001 enters human trials

NCT ID NCT07208149

Disease control Sponsor: Shenzhen Majory Biotechnology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called MR001 in people with advanced triple-negative breast cancer (TNBC) whose cancer has worsened after standard treatments. The main goals are to check the drug's safety, find the best dose, and see if it can shrink tumors. About 42 participants will receive MR001 in a clinic setting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple negative breast cancer (TNBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.