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. 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…
The initial dose is 500 μg/kg Q2W. The drug will be administered on D1/D15 of each cycle. The maximum duration of administration is tentatively set at 2 years.
ANO31905: If the lower dose is tolerated, a higher dose of 800 μg/kg will be administered to the subjects. ANO31905 will be administered on D1/D15 of each cycle. The maximum duration of administration is tentatively set at 2 years.
125 mg/m\^2, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).
1000 mg/m\^2, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).
Arctuva estimate
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