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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
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).
Dose-limiting toxicity (DLT) (Phase Ib).
The severity of adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events Version 6.0 (the severity of cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\] will be graded per the American Society for Transplantation and Cellular Therapy \[ASTCT\] consensus criteria). AEs that occur during the DLT observation period and are judged to be "definitely related", "probably related", or "possibly related" to any investigational products (ANO31905, GEM, Nab-P) will be deemed as a DLT event.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ)
Objective response rate (ORR) is defined as the proportion of patients with the best efficacy evaluation of complete response (CR) or partial response (PR) during the study. From date of treatment start until disease progression, date of death or withdrawal from study, whichever came first.
Time frame: Up to 12 months
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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).