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

NCT07208149 | Recruiting Phase 1

• 1 other identifier: MJR-MR001-03
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple-Negative Breast Cancer (TNBC)

Outcome Measures

Primary Outcomes (3)

• Number of participants who experience one or more dose-limiting toxicities (DLTs)

  Approximately 6 months

• Maximum Tolerated Dose (MTD) of MR001

  The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules

  Approximately 6 months

• Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0

  Approximately 2 years

Secondary Outcomes (12)

• Recommended Phase II Dose (RP2D) based on safety, pharmacodynamics, pharmacokinetics and Preliminary Anti-tumor Activity of MR001

  Approximately 6 months

• Progression-free survival (PFS)

  Approximately 2 years

• Duration of response (DOR)

  Approximately 2 years

• Overall survival (OS)

  Approximately 3 years

• Objective Response Rate (ORR)

  Approximately 2 years

Study Arms (5)

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

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

Drug: MR001 Bispecific Antibody for Injection

Interventions

MR001 Bispecific Antibody for Injection DRUG

Intravenous infusion

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Majory Biotechnology Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Binghe Xu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingshan Xue

CONTACT

+86 13332895357; xueqs@majory.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 6, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2025-09

Locations

CN (1)