Efficacy and Safety of LM-302 Combined With Gemcitabine CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Inclusion criteria

• ✓. Capable of providing written informed consent, understanding and complying with study requirements. Willing to participate after full disclosure of the study's purpose, procedures, potential risks, and benefits, and must sign the informed consent form before any study-related procedures.
• ✓. Age ≥18 years old.
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks before the first dose.
• ✓. Expected survival ≥3 months.
• ✓. Histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) not amenable to curative treatment.
• ✓. Must have experienced disease progression or intolerance to first-line standard therapy containing 5-FU (fluorouracil) (radiologically confirmed).
• ✓. At least one measurable lesion per RECIST v1.1.
• ✓. Must provide 5-7 unstained slides from archived (within 3 years) or fresh tumor tissue for CLDN18.2 and other biomarker testing. CLDN18.2 positivity defined as: Moderate-to-high staining intensity (2+\~3+) in ≥50% of tumor cells, as assessed by central laboratory IHC (immunohistochemistry).

Exclusion criteria