Shanghai Lingda Biological Medicine Co., Ltd.

Main study objectives: Dose escalation phase: 1) Evaluate the safety and tolerability of RG002 tablets in patients with advanced solid tumors; 2) Determine the maximum tolerated dose (MTD) of RG002 tablets; 3) Determine the recommended dose (RP2D) of RG002 tablets for Phase II clinical studies; Dose expansion phase: Evaluate the anti-tumor efficacy of RG002 tablets in patients with advanced solid tumors with FGF/FGFR gene changes; Secondary study objectives: Dose escalation phase: 1) Evaluate the pharmacokinetics and serum phosphorus pharmacodynamic characteristics of RG002 tablets in patients with advanced solid tumors; 2) Preliminary evaluation of the anti-tumor efficacy of RG002 tablets in patients with advanced solid tumors; Dose expansion phase: 1) Evaluate the serum phosphorus pharmacodynamic characteristics of RG002 tablets in patients with advanced solid tumors with FGF/FGFR gene changes; 2) To evaluate the safety and tolerability of RG002 tablets in patients with advanced solid tumors with FGF/FGFR gene changes; Purpose of exploratory study: To explore the correlation between FGF/FGFR gene changes and efficacy.

Primary objective: To evaluate the safety and tolerability of RG001 tablets in patients with advanced solid tumors who have failed standard treatment, and to explore the maximum tolerated dose (MTD) of RG001 tablets and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of RG001 tablets; 2) To preliminarily evaluate the efficacy of RG001 tablets in patients with advanced solid tumors.