Anova Innovation Limited
The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer.
Inclusion Criteria: 1. Patients voluntarily participate in the study and sign the written ICF; 2. Males or females aged ≥ 18 at the time of signing the ICF; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 4. Expected survival ≥ 3 months; 5. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous cell carcinoma) which is locally advanced unresectable or metastatic with the first diagnosis within 3 months before the first dose (clinical staging criteria are based on AJCC 8th edition); 6. Those who have not re…
ANO31905 will be administered as an IV infusion
125 mg/m\^2 of nab-paclitaxel, intravenous infusion, D1/D8/D15 per cycle; 1000 mg/m\^2 of gemcitabine, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity or other discontinuation criteria specified in the protocol (whichever occurs first).
Oxaliplatin, 85 mg/m\^2; irinotecan (non-liposome injection), 180 mg/m\^2; leucovorin, 400 mg/m\^2; and fluorouracil, 2400 mg/m\^2 given as a 46-hour continuous infusion, on D1/D15 per cycle.
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