Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation
Starting soon · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Pancreatic Cancer, Pancreatic Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07656376
- Run by
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
- People needed
- 465
- Starts
- 2027-06-06
- Expected to finish
- 2029-05-08
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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