This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation.The study consists of two stages I, Stage I ：explores the combination dose and the second phase; Stage II ：patients were randomized 1:1 to receive either the experimental regimen DN022150 plus AG or the control regimen AG alone.
Voluntarily signed informed consent form
Age 18-75 years (inclusive), male or female, at the time of signing informed consent
Life expectancy ≥ 12 weeks
Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer
Progression or other malignancy requiring treatment within 5 years prior to enrollment
Prior targeted therapy for KRAS G12D
With central nervous system metastasis
Uncontrolled fluid accumulation
Parallel
DN022150+AG( Stage I ）
Drug28-day /cycle
DN022150+AG（Stage II）
Drug28-day /cycle
placebo+AG（Stage II）
Drug28-day /cycle
DLT
stage I ：To evaluate the safety and tolerability of different doses of DN022150 for Injection combined with AG regimen in participants with locally advanced or metastatic pancreatic cancer, including the incidence of dose limiting toxicity (DLT), explore the MTD, and determine the RP3D of DN022150 for Injection combined with AG regimen in combination with PK and efficacy data
PFS as assessed by BICR per RECIST 1.1
stage II
OS
stage II
ORR
stage I
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0
stage I\&II
DOR as assessed by the investigator per RECIST v1.1
stage I
Cmin, ss
stage I\&II: Steady State Trough Concentration
Pancreatic cancer quality of life specific scale
stage II
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