A Study of Dose Escalation of ES502 in Patients With Advanced Pancreatic Cancer

Inclusion criteria

• . Age ≥18 years, regardless of gender;
• . Available fresh or archived tumor tissue samples (within the past 5 years) for testing at screening;
• . Individuals with histologically or cytologically confirmed advanced solid tumors for whom no standard therapy exists, who are refractory to standard therapy, or who are deemed unsuitable for standard therapy by the investigator. Tumor types include but are not limited to: pancreatic cancer, colorectal cancer, non-small cell lung cancer, intrahepatic cholangiocarcinoma, gallbladder cancer, ovarian cancer, endometrial cancer, and intestinal cancer;
• . RAS G12V mutation (KRAS/NRAS/HRAS) and positivity for HLA-DPB1\*03:01, \*14:01, \*25:01, or \*104:01;
• . Individuals with at least one measurable lesion (defined per RECIST v1.1 as a lesion with the longest diameter ≥10 mm, or a lymph node with a short axis of ≥15 mm); lesions that have undergone radiotherapy or other local therapies are not considered target lesions unless they demonstrate clear progression;
• . ECOG score: 0-1;
• . Expected survival greater than 3 months;
• . Adequate hematological and organ function, as evidenced by the following laboratory tests (the individual must not have received a blood transfusion, long-acting EPO or long-acting G-CSF within 14 days before study treatment, or not have received short-acting EPO or short-acting G-CSF within 7 days before study treatment): 1) hematology: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count (PLT) ≥100 × 10⁹/L, hemoglobin (Hb) ≥90 g/L; 2) liver function test: both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5 × ULN. Exceptions: liver metastasis, AST and/or ALT ≤5 × ULN; Gilbert's syndrome, TBIL ≤3 × ULN; pancreatic head cancer or biliary obstruction, TBIL ≤3 × ULN; 3) kidney function test: creatinine clearance (CrCL) ≥50 mL/min (by Cockcroft-Gault formula); 4) coagulation function test: activated partial thromboplastin time (APTT) ≤1.5 × ULN and international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN; 5) echocardiography: left ventricular ejection fraction (LVEF) ≥50%; eligibility for enrollment of individuals with out-of-range laboratory results should be determined at the investigator's discretion.