NCT07656376Not yet recruitingPhase 2/3
Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 465 (estimated)
- First submitted
- 5 Jun 2026
- Start date
- 6 Jun 2027
- Primary completion date
- 7 Feb 2029
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
- Diseases
- Pancreatic cancer
- NCT number
- NCT07656376
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 465
- From 6 Jun 2027 to the primary completion date, 7 Feb 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Progression or other malignancy requiring treatment within 5 years prior to enrollment
- Prior targeted therapy for KRAS G12D
- 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;
Other illness
- History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
Other
- With central nervous system metastasis
- Uncontrolled fluid accumulation
- Other situations not suitable for the study judged by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.