KY-0301

The main objectives of the Phase I dose escalation phase and dose expansion phase are as follows: 1. To evaluate the safety and tolerability of KY-0301 in patients with unresectable locally advanced or metastatic solid tumors [including but not limited to epidermal growth factor receptor (EGFR) wild-type or mutant non-squamous non-small cell lung cancer, squamous non-small cell lung cancer, colorectal cancer, advanced gastric cancer/esophageal gastric junction adenocarcinoma, head and neck squamous cell carcinoma, etc.]; 2. To determine the maximum tolerated dose (MTD) and recommended expansion dose [RED(s)] of KY0301 in patients with unresectable locally advanced or metastatic solid tumors; 3. To determine the Phase II recommended dose (RP2D) of KY-0301 in patients with unresectable locally advanced or metastatic solid tumors. The main objectives of the Phase II cohort expansion phase are as follows: To evaluate the preliminary efficacy of KY-0301 in the treatment of patients with planned unresectable locally advanced or metastatic solid tumors at the determined RP2D.