This study is a multicenter, open, single-arm Phase I/II clinical study, which is divided into two research parts, namely phase I dose exploration study and phase II dose extension study. In the phase I dose exploration study, the safety, tolerance and PK characteristics of FCN-011 in patients with advanced solid tumors were determined, the MTD of oral fCN-011 was determined, and the RP2D of FCN-011 in the phase II clinical study was determined, and the efficacy of FCN-011 was preliminarily evaluated. The phase II dose extension study evaluated the efficacy, safety, and tolerability of continuous oral ADMINISTRATION of FCN-011 in patients with inoperable NTRK fusion and advanced stage III or IV solid tumors, as well as the characteristics of population pharmacokinetics (PopPK).~A total of 35-82 patients were enrolled in this study, 15-24 patients were expected to be enrolled in the phase I study, and 20-58 patients were expected to be enrolled in the phase II study.
A multicenter, open, single-arm phase I dose exploration and phase II extended study was conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary antitumor activity of FCN-011 in patients with advanced solid tumor (phase I) and NTRK fusion positive advanced solid tumor (phase II)