Pancreatic CancerPhase 3NCT07689539
Trial of DN022150 Versus Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation
A Phase 3 study testing DN022150 and Chemotherapy in people with Pancreatic Cancer, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- DN022150 and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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;
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
Read the detailed description
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
- Conditions
- Pancreatic Cancer
- Being tested
- DN022150, Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DN022150Drug
iv QW 28-day/cycle
ChemotherapyDrug
Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1
| Study group | Role | What they receive |
|---|---|---|
| DN022150 | Experimental | iv, QW, 28day/cycle Receives: Drug: DN022150 |
| Chemotherapy | Active comparator | nal-IRI+5-FU/LV，AG or S-1 Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Evaluated by Blinded Independent Central Review (BIRC)
Measured: up to 2 years
Overall Survival (OS)
Measured: up to 2 years
Secondary outcomes (13)
Progression-Free Survival (PFS)
Evaluated by Investigator
Measured: up to 2 years
Objective Response Rate (ORR)
Measured: up to 2 years
Duration of Response (DoR)
Measured: up to 2 years
Disease Control Rates (DCR)
Measured: up to 2 years
Time to Response (TTR）
Measured: up to 2 years
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0
Measured: up to 2 years
AUC0-t
Measured: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
AUC0-inf
Measured: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
Cmax
Measured: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
Cmin
Measured: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
t1/2
Measured: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
EORTC QLQ-C30（European Organization for Research and Treatment of Cancer Quality of Life Questionnaire）
scale 0-100，higher scores mean a worse outcome
Measured: up to 2 years
EORTC QLQ-PAN26（European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer 26）
scale 0-100，higher scores mean a worse outcome
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689539
- Sponsor's protocol ID
- DN022150-302
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07689539
- Acronym / sponsor ID
- DN022150-302
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DN022150 | Experimental | Drug: DN022150iv, QW, 28day/cycle |
| Chemotherapy | Active comparator | Drug: Chemotherapynal-IRI+5-FU/LV，AG or S-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DN022150iv QW 28-day/cycle | Drug | DN022150 |
| ChemotherapyInvestigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1 | Drug | Chemotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: up to 2 years
Evaluated by Blinded Independent Central Review (BIRC)
Overall Survival (OS)
Time frame: up to 2 years
13 secondary outcomes
Progression-Free Survival (PFS)
Time frame: up to 2 years
Objective Response Rate (ORR)
Time frame: up to 2 years
Duration of Response (DoR)
Time frame: up to 2 years
Disease Control Rates (DCR)
Time frame: up to 2 years
Time to Response (TTR）
Time frame: up to 2 years
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0
Time frame: up to 2 years
AUC0-t
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
AUC0-inf
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
Cmax
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
Cmin
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
t1/2
Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）
EORTC QLQ-C30（European Organization for Research and Treatment of Cancer Quality of Life Questionnaire）
Time frame: up to 2 years
EORTC QLQ-PAN26（European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer 26）
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DN022150 and Chemotherapy in people with Pancreatic Cancer, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Man (+86 19979703650, xuman@kvvit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.