Nanjing Nadingfei Pharmaceutical Technology Co., Ltd.

Primary objectives: 1) Determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of NP-01 tablets in patients with advanced malignant solid tumors and/or determine the recommended dose of NP-01 tablets for subsequent studies; 2) Evaluate the safety and tolerability of NP-01 tablets in patients with advanced malignant solid tumors. Secondary objectives: 1) Evaluate the pharmacokinetic characteristics of NP-01 tablets in patients with advanced malignant solid tumors to provide a basis for subsequent clinical studies; 2) According to the RECIST1.1 standard, observe the objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS), and preliminarily evaluate the efficacy of NP-01 tablets in the treatment of patients with advanced malignant solid tumors. Exploratory purpose: 1) Using serum VEGF and other indicators, preliminarily explore the construction of PK/PD models, and preliminarily explore clinical prediction models, simulate the clinical efficacy and safety of different doses, and provide support for the formulation of the next clinical plan; 2) Only the expansion phase: using the objective response rate (ORR) as the clinical endpoint to preliminarily explore the efficacy in tumor patients with different biomarkers as indicators, potential biomarkers include Met, KDR (tissue), etc. 3) Only the expansion phase: explore the sensitivity and mechanism of NP-01 tablets to different biomarkers of solid tumor patients.