Clinical Research Directory

Inclusion Criteria: 1. Males or females aged ≥ 18 at the time of signing the ICF; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 3. Expected survival ≥ 3 months; 4. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma; 5. At least one measurable lesion according to RECIST v1.1; 6. Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory; 7. Patients with sufficient organ function within 7 days before the first study dose; 8. Non-pregnant or -lactating women. Exclusion Criteria: 1. Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment; Any previous systematic anti-cancer therapy 2. Any previous systematic anti-cancer therapy; 3. Previous treatment targeting CLDN18.2; 4. Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment; 5. Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel; 6. Patients with known metastases to the central nervous system; 7. Patients with severe cardiovascular and cardiovascular diseases; 8. Presence risks of thrombosis or bleeding; 9. Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines during study treatment; 10. Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator; 11. Patients with other conditions that may place the patients at increased undue study-related risks.