Triple-Negative Breast Cancer (TNBC)Phase 1/2NCT07208149
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
A Phase 1/2 study testing MR001 Bispecific Antibody for Injection in people with Triple-Negative Breast Cancer (TNBC), run by Shenzhen Majory Biotechnology Co., Ltd. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- MR001 Bispecific Antibody for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesChina
- Study dates
- 29 Jan 2026to 1 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Binghe Xu, +86-10-87788826, xubinghe@medmail.com.cn
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei
Yanxia Zhao, +86 13407192551, sophia7781@126.com
- Not yet recruiting
Hunan Cancer Hospital
Hunan
Quchang Ouyang, +86 13973135318, oyqc1969@126.com
About this study
Official title: 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
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.
Read the detailed description
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
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- MR001 Bispecific Antibody for Injection
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR001 Bispecific Antibody for InjectionDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Part, Dose Group A: MR001 1 mg/kg, QW | Experimental | Not described Receives: Drug: MR001 Bispecific Antibody for Injection |
| Dose Escalation Part, Dose Group B: MR001 2 mg/kg, QW | Experimental | Not described Receives: Drug: MR001 Bispecific Antibody for Injection |
| Dose Escalation Part, Dose Group C: MR001 4 mg/kg, QW | Experimental | Not described Receives: Drug: MR001 Bispecific Antibody for Injection |
| Dose Escalation Part, Dose Group D: MR001 2 mg/kg, Q2W | Experimental | Not described Receives: Drug: MR001 Bispecific Antibody for Injection |
| Dose Expansion Part | Experimental | 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 Receives: Drug: MR001 Bispecific Antibody for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Measured: Approximately 6 months
Maximum Tolerated Dose (MTD) of MR001
The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Measured: Approximately 6 months
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0
Measured: Approximately 2 years
Secondary outcomes (12)
Recommended Phase II Dose (RP2D) based on safety, pharmacodynamics, pharmacokinetics and Preliminary Anti-tumor Activity of MR001
Measured: Approximately 6 months
Progression-free survival (PFS)
Measured: Approximately 2 years
Duration of response (DOR)
Measured: Approximately 2 years
Overall survival (OS)
Measured: Approximately 3 years
Objective Response Rate (ORR)
Measured: Approximately 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of MR001
Measured: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)
Maximum Plasma Concentration (Cmax) of MR001
Measured: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)
Time to Maximum Plasma Concentration (Tmax) of MR001
Measured: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)
Change from baseline at different time points for TGF-β1 in plasma
Measured: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)
Change from baseline at different timepoints for Th1 of MR001
Measured: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)
Change from baseline at different timepoints for Th2 of MR001
Measured: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)
Incidence of Antidrug Antibodies (ADA) to MR001
Measured: Predose in each cycle for approximately 2 years (each cycle = 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start29 Jan 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Majory Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesQuchang Ouyang, Principal investigator, Hunan Cancer HospitalYanxia Zhao, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208149
- Sponsor's protocol ID
- MJR-MR001-03
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07208149
- Acronym / sponsor ID
- MJR-MR001-03
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shenzhen Majory Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Part, Dose Group A: MR001 1 mg/kg, QW | Experimental | Drug: MR001 Bispecific Antibody for Injection |
| Dose Escalation Part, Dose Group B: MR001 2 mg/kg, QW | Experimental | Drug: MR001 Bispecific Antibody for Injection |
| Dose Escalation Part, Dose Group C: MR001 4 mg/kg, QW | Experimental | Drug: MR001 Bispecific Antibody for Injection |
| Dose Escalation Part, Dose Group D: MR001 2 mg/kg, Q2W | Experimental | Drug: MR001 Bispecific Antibody for Injection |
| Dose Expansion Part | Experimental | Drug: MR001 Bispecific Antibody for InjectionBased on the Dose escalation part results, the Investigator and Sponsor will determine one dose and dosing interval to proceed to the dose expansion study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR001 Bispecific Antibody for InjectionIntravenous infusion | Drug | Dose Escalation Part, Dose Group A: MR001 1 mg/kg, QW, Dose Escalation Part, Dose Group B: MR001 2 mg/kg, QW, Dose Escalation Part, Dose Group C: MR001 4 mg/kg, QW, Dose Escalation Part, Dose Group D: MR001 2 mg/kg, Q2W, Dose Expansion Part |
Primary outcome
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Time frame: Approximately 6 months
Maximum Tolerated Dose (MTD) of MR001
Time frame: Approximately 6 months
The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0
Time frame: Approximately 2 years
12 secondary outcomes
Recommended Phase II Dose (RP2D) based on safety, pharmacodynamics, pharmacokinetics and Preliminary Anti-tumor Activity of MR001
Time frame: Approximately 6 months
Progression-free survival (PFS)
Time frame: Approximately 2 years
Duration of response (DOR)
Time frame: Approximately 2 years
Overall survival (OS)
Time frame: Approximately 3 years
Objective Response Rate (ORR)
Time frame: Approximately 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)
Maximum Plasma Concentration (Cmax) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)
Time to Maximum Plasma Concentration (Tmax) of MR001
Time frame: Predose and at designated timepoints in each cycle for approximately 2 years (each cycle = 2 weeks)
Change from baseline at different time points for TGF-β1 in plasma
Time frame: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)
Change from baseline at different timepoints for Th1 of MR001
Time frame: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)
Change from baseline at different timepoints for Th2 of MR001
Time frame: Predose and at designated timepoints during the first three cycles (each cycle = 2 weeks)
Incidence of Antidrug Antibodies (ADA) to MR001
Time frame: Predose in each cycle for approximately 2 years (each cycle = 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Binghe Xu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Quchang Ouyang principal investigator
Hunan Cancer Hospital
Yanxia Zhao principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MR001 Bispecific Antibody for Injection in people with Triple-Negative Breast Cancer (TNBC), run by Shenzhen Majory Biotechnology Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingshan Xue (+86 13332895357, xueqs@majory.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experience one or more dose-limiting toxicities (DLTs) (time frame: Approximately 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.