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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
465
28-day /cycle
28-day /cycle
28-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
Time frame: up to 2 years
PFS as assessed by BICR per RECIST 1.1
stage II
Time frame: up to 2 years
OS
stage II
Time frame: up to 2 years
ORR
stage I
Time frame: up to 2 years
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0
stage I\&II
Time frame: up to 2 years
DOR as assessed by the investigator per RECIST v1.1
stage I
Time frame: up to 2 years
Cmin, ss
stage I\&II: Steady State Trough Concentration
Time frame: up to 2 year
Pancreatic cancer quality of life specific scale
stage II
Time frame: up to 2 years
DCR as assessed by the investigator per RECIST v1.1
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stage I
Time frame: up to 2 years
PFS assessed by the investigator per RECIST v1.1
stage I
Time frame: up to 2 years
OS
stage I
Time frame: up to 2 years
PFS as assessed by the investigator per RECIST v1.1
stage II
Time frame: up to 2 years
ORR as assessed by the investigator or BICR per RECIST v1.1
stage II
Time frame: up to 2 years
DOR as assessed by the investigator or BICR per RECIST v1.1
stage II
Time frame: up to 2 years
DCR as assessed by the investigator or BICR per RECIST v1.1
stage II
Time frame: up to 2 years
Cmax,ss
Maximum Steady-State Plasma Concentration
Time frame: up to 2years
AUC0-t
stage I\&II AUC from time 0 to last measurable time
Time frame: up to 2years
t1/2
stageI\&II Half-life
Time frame: up to 2years