Study design
toxicity, tumor
DISEASE PROGRESSION, TUMOR
Patients enrolled in this study were divided into two parts. In Part A, patients were enrolled into the 300 mg QD, 450 mg QD and 600 mg QD dose cohorts, the tumor samples collected during the pre-screening period were detected by IHC staining, and IHC staining score was detected as ≥ 2 + could be enrolled. Patients with pre-existing c-MET overexpression at hospital diagnosis were also included in Part A. In Part B, patients in the 400 mg bis in die (BID) dose cohort, blood and tissue samples were collected to perform NGS to determine the Based on a previous population PK model analysis (data unpublished), following 400 mg BID, area under the concentration-time curve (AUC) values for both BPI-9016M and its main plasma metabolites were comparable with that at 800 mg QD, and trough concentration relatively elevated whereas maximum concentration (CImaging examinations including computed tomography (CT), cranial contrast-enhanced CT or magnetic resonance imaging were performed every eight weeks at the first 12 cycles, and every 12 weeks thereafter. For patients with disease progression, they could continue the BPI-9016M treatment if the investigator and sponsor assessed that BPI-9016M could still bring benefit. Dose adjustment was allowed according to the severity of toxicity [Supplementary Table 