Zelgen Pharmaceutical (Zhejiang) Co., Ltd

Phase I - Single-drug dose escalation and food effect on ZG2001 drug metabolism Dose escalation part, main purpose: to investigate the safety and tolerability of ZG2001 monotherapy in patients with advanced solid tumors carrying KRAS mutations who have progressed, are intolerant or have no standard treatment, and to investigate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) that may occur in the set dose group. Study of food effect on ZG2001 drug metabolism, main purpose: to study the effect of food on ZG2001 metabolism at the recommended dose. Phase II - ZG2001 monotherapy expansion study phase Main purpose: to investigate the efficacy of ZG2001 (RP2D) monotherapy in patients with advanced solid tumors carrying KRAS mutations (such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, etc.) who have failed at least one line of standard treatment. Exploratory purpose: to analyze the relationship between potential biomarkers (such as SOS1, PTPN11, NF1) and efficacy.