BYS-10

Phase I: Primary objective: To evaluate the safety and tolerability of BYS10 tablets in patients with advanced solid tumors; to determine the maximum tolerated dose and subsequent recommended dose of BYS10 tablets. Secondary objectives: To describe the pharmacokinetic (PK) characteristics of BYS10 tablets and analyze the relationship between drug exposure and safety; to evaluate the anti-tumor efficacy of BYS10 tablets in patients with advanced solid tumors; to analyze the RET gene status in blood and/or tumor tissues and its relationship with anti-tumor efficacy; to detect changes in pharmacodynamic (PD) indicators after oral administration of BYS10 tablets and PK/PD correlation analysis. Phase II: Primary objective: To evaluate the objective response rate of BYS10 tablets in patients with advanced non-small cell lung cancer, thyroid cancer, medullary thyroid cancer and other advanced solid tumors with RET gene fusion or mutation; to further evaluate the safety and tolerability of BYS10 tablets. Secondary objectives: Evaluation of other anti-tumor efficacy indicators: including DOR, DCR, TTR, PFS, CBR and OS; analysis of RET gene status in blood and/or tumor tissue, and its relationship with anti-tumor efficacy; description of the PK characteristics of BYS10 tablets in patients with advanced solid tumors with RET gene fusion or mutation, and analysis of the relationship between drug exposure and safety and anti-tumor efficacy; detection of changes in PD indicators after oral administration of BYS10 tablets and PK/PD correlation analysis; evaluation of the efficacy of BYS10 tablets in patients with NSCLC brain metastases.