Module 1B-1
TNBC
DISEASE, METASTASIS
A single arm expansion was conducted to refine the safety, tolerability, PK, and pharmacodynamic profiles of samuraciclib monotherapy (360 mg OD) in male or female patients with advanced TNBC. Patients with histological, radiological or cytological confirmation of metastasis or locally advanced TNBC not considered to be appropriate for further standard treatment, who had received at least 1 line of systemic anti-cancer therapy, and measurable disease according to the RECIST V1.1, were eligible.Patients underwent regular safety monitoring and 8-week scans reported using RECIST V1.1.