NCT07689539Not yet recruitingPhase 3
Trial of DN022150 Versus Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation
A Phase 3, Multicenter, Open-Label, Randomized, Controlled Trial of DN022150 Monotherapy Versus Investigator's Choice Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 21 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
- Diseases
- Pancreatic cancer
- NCT number
- NCT07689539
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 360
- From Sept 2026 to the primary completion date, Jul 2028
- 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
- 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 received prior systemic 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.