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

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

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.

Inclusion Criteria:

1. Voluntarily signed informed consent form
2. Age 18-75 years (inclusive), male or female, at the time of signing informed consent
3. Life expectancy ≥ 12 weeks
4. Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer
5. ECOG score of performance status 0 ~ 1
6. At least one measurable lesion by RECIST v1.1 criteria
7. Adequate organ function
8. Effective methods of contraception during the study

Exclusion Criteria:

1. Progression or other malignancy requiring treatment within 5 years prior to enrollment
2. Prior targeted therapy for KRAS G12D
3. With central nervous system metastasis
4. Uncontrolled fluid accumulation
5. Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment
6. Concomitant clinically significant cardiovascular disease
7. Concurrent major acute or chronic infectious disease
8. 4. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;
9. History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
10. Other situations not suitable for the study judged by the investigator