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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Qingshan Xue
xueqs@majory.com.cn
+86 13332895357
Time Frame
Start Date: 2026-01-29
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 42
Treatments
Experimental: Dose Escalation Part, Dose Group A: MR001 1 mg/kg, QW
Experimental: Dose Escalation Part, Dose Group B: MR001 2 mg/kg, QW
Experimental: Dose Escalation Part, Dose Group C: MR001 4 mg/kg, QW
Experimental: Dose Escalation Part, Dose Group D: MR001 2 mg/kg, Q2W
Experimental: Dose Expansion Part
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
Related Therapeutic Areas
Sponsors
Leads: Shenzhen Majory Biotechnology Co., Ltd.