ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Inclusion criteria

• Males or females aged ≥ 18 at the time of signing the ICF;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Expected survival ≥ 3 months;
• Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;
• At least one measurable lesion according to RECIST v1.1;
• Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory;
• Patients with sufficient organ function within 7 days before the first study dose;
• Non-pregnant or -lactating women.

Exclusion criteria

• 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
• Any previous systematic anti-cancer therapy;
• Previous treatment targeting CLDN18.2;
• Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment;
• Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel;
• Patients with known metastases to the central nervous system;
• Patients with severe cardiovascular and cardiovascular diseases;
• Presence risks of thrombosis or bleeding;
• 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;
• Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator;
• Patients with other conditions that may place the patients at increased undue study-related risks.