FCN-011

The main objectives of the Phase I study are: (1) to observe the safety and tolerability of single oral and continuous oral FCN-011 monotherapy in patients with unresectable stage III or IV advanced solid tumors; (2) to determine the maximum tolerated dose (MTD) and recommended dose (RP2D) of FCN-011 for Phase II clinical studies. The secondary objectives of the Phase I study are: (1) to preliminarily observe the anti-tumor efficacy of oral FCN? 011 in patients with advanced solid tumors; (2) to evaluate the pharmacokinetic (PK) characteristics of FCN? 011. The main objectives of the Phase II study are: to evaluate the efficacy of continuous oral FCN-011 monotherapy in patients with NTRK fusion-positive, unresectable stage III or IV advanced solid tumors. The secondary objectives of the Phase II study are: (1) to evaluate the safety and tolerability of continuous oral monotherapy of FCN-011 in patients with NTRK fusion-positive, unresectable, stage III or IV advanced solid tumors; (2) to evaluate the PK characteristics of FCN-011 (if necessary after the completion of the Phase I study); and (3) to preliminarily evaluate the population pharmacokinetic (PopPK) characteristics of FCN-011.