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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Intravenous infusion
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGNumber of participants who experience one or more dose-limiting toxicities (DLTs)
Time frame: Approximately 6 months
Maximum Tolerated Dose (MTD) of MR001
The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Time frame: Approximately 6 months
Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0
Time frame: Approximately 2 years
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)