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Pancreatic CancerPhase 2/3NCT07656376

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

A Phase 2/3 study testing DN022150+AG( Stage I ） and DN022150+AG（Stage II） in people with Pancreatic Cancer and Pancreatic Carcinoma, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer, Pancreatic Carcinoma
What is being tested?
DN022150+AG( Stage I ） and DN022150+AG（Stage II）
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
465 participants
Where
No sites listed yet
Study dates
6 Jun 2027to 8 May 2029
Phase
Phase 2/3
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 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

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
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Man Xu contact

+86 19979703650

xuman@kvvit.com

About this study

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.

Being tested
DN022150+AG( Stage I ）, DN022150+AG（Stage II）, placebo+AG（Stage II）
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DN022150+AG( Stage I ）Drug

    Also called Dose-finding group

    28-day /cycle

  • DN022150+AG（Stage II）Drug

    Also called Test group

    28-day /cycle

  • placebo+AG（Stage II）Drug

    Also called Control group

    28-day /cycle

Study groups in NCT07656376
Study groupRoleWhat they receive
DN022150+AG( Stage I ）ExperimentalStage I，To evaluate the safety and tolerability of two different doses of DN022150 for Injection combined with AG regimen preset, and to determine the recommended dose of DN022150 for Injection combined with AG regimen for efficacy expansion based on the PK and preliminary efficacy data. After the completion of efficacy expansion, the safety, tolerability, PK and preliminary efficacy data of the first phase will be synthesized to confirm the RP3D of DN022150 combined with AG regimen
Receives: Drug: DN022150+AG( Stage I ）
DN022150+AG（ Stage II）ExperimentalStage II DN022150（ RP3D)+AG
Receives: Drug: DN022150+AG（Stage II）
DN022150 placebo+AG（ Stage II）Placebo comparatorStage II DN022150 placebo+AG
Receives: Drug: placebo+AG（Stage II）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    stage I ：To evaluate the safety and tolerability of different doses of DN022150 for Injection combined with AG regimen in participants with locally advanced or metastatic pancreatic cancer, including the incidence of dose limiting toxicity (DLT), explore the MTD, and determine the RP3D of DN022150 for Injection combined with AG regimen in combination with PK and efficacy data

    Measured: up to 2 years

  2. PFS as assessed by BICR per RECIST 1.1

    stage II

    Measured: up to 2 years

  3. OS

    stage II

    Measured: up to 2 years

  4. ORR

    stage I

    Measured: up to 2 years

Secondary outcomes (14)

  1. Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0

    stage I\&II

    Measured: up to 2 years

  2. DOR as assessed by the investigator per RECIST v1.1

    stage I

    Measured: up to 2 years

  3. Cmin, ss

    stage I\&II: Steady State Trough Concentration

    Measured: up to 2 year

  4. Pancreatic cancer quality of life specific scale

    stage II

    Measured: up to 2 years

  5. DCR as assessed by the investigator per RECIST v1.1

    stage I

    Measured: up to 2 years

  6. PFS assessed by the investigator per RECIST v1.1

    stage I

    Measured: up to 2 years

  7. OS

    stage I

    Measured: up to 2 years

  8. PFS as assessed by the investigator per RECIST v1.1

    stage II

    Measured: up to 2 years

  9. ORR as assessed by the investigator or BICR per RECIST v1.1

    stage II

    Measured: up to 2 years

  10. DOR as assessed by the investigator or BICR per RECIST v1.1

    stage II

    Measured: up to 2 years

  11. DCR as assessed by the investigator or BICR per RECIST v1.1

    stage II

    Measured: up to 2 years

  12. Cmax，ss

    Maximum Steady-State Plasma Concentration

    Measured: up to 2years

  13. AUC0-t

    stage I\&II AUC from time 0 to last measurable time

    Measured: up to 2years

  14. t1/2

    stageI\&II Half-life

    Measured: up to 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study start6 Jun 2027 (estimated)
  3. Primary completion7 Feb 2029 (estimated)
  4. Study completion8 May 2029 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
465 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07656376
Sponsor's protocol ID
DN022150-301
Status last verified
Jun 2026
First submitted
5 Jun 2026
Last updated
18 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DN022150+AG( Stage I ） and DN022150+AG（Stage II） in people with Pancreatic Cancer and Pancreatic Carcinoma, 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 18 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Man Xu (+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?

DLT (time frame: up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07656376.

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 18 Jun 2026.

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