Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation

Inclusion criteria

• 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
• ECOG score of performance status 0 ~ 1
• At least one measurable lesion by RECIST v1.1 criteria
• Adequate organ function
• Effective methods of contraception during the study

Exclusion criteria

• 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
• Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment
• Concomitant clinically significant cardiovascular disease
• Concurrent major acute or chronic infectious disease
• 4. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;
• History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
• Other situations not suitable for the study judged by the investigator