This study plans to enroll participants with previously treated advanced pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. Eligible participants will be randomized 1:1 to DN022150 Monotherapy or Investigator's Choice Chemotherapy
This study plans to enroll participants with previously treated advanced pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. Eligible participants will be randomized 1:1 to DN022150 Monotherapy or Investigator's Choice Chemotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
iv QW 28-day/cycle
Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1
Progression-Free Survival (PFS)
Evaluated by Blinded Independent Central Review (BIRC)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Evaluated by Investigator
Time frame: up to 2 years
Objective Response Rate (ORR)
Time frame: up to 2 years
Duration of Response (DoR)
Time frame: up to 2 years
Disease Control Rates (DCR)
Time frame: up to 2 years
Time to Response (TTR)
Time frame: up to 2 years
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0
Time frame: up to 2 years
AUC0-t
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle)
AUC0-inf
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle)
Cmax
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle)
Cmin
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle)
t1/2
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle)
EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)
scale 0-100,higher scores mean a worse outcome
Time frame: up to 2 years
EORTC QLQ-PAN26(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer 26)
scale 0-100,higher scores mean a worse outcome
Time frame: up to 2 years