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New drug combo targets tough pancreatic cancer gene

NCT ID NCT07656376

Disease control Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called DN022150 combined with standard chemotherapy (AG) as a first treatment for advanced pancreatic cancer that has a specific genetic change called KRAS G12D. About 465 adults aged 18-75 who have not had prior treatment for advanced disease will take part. The trial has two stages: first to find the best dose, then to compare the drug combo against chemo alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DN022150 (a targeted drug) combined with AG chemotherapy (gemcitabine and nab-paclitaxel)
What this could lead to
If successful, this could provide a new first-line treatment option for people with a specific genetic type of advanced pancreatic cancer, potentially improving how long they live.
What could go wrong
This is an early-to-mid stage trial combining a new drug with standard chemo. The new drug may not add benefit, could cause added side effects, and results may not apply to all pancreatic cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 465 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily signed informed consent form 2. Age 18-75 years (inclusive), male or female, at the time of signing informed consent 3. Life expectancy ≥ 12 weeks 4. Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer 5. ECOG score of performance status 0 \~ 1 6. At least one measurable lesion by RECIST v1.1 criteria 7. Adequate organ function 8. Effective methods of contraception during the study Exclusion Criteria: 1. Progression or other malignancy requiring treatment within 5 years prior to enrollment 2. Prior targeted therapy for KRAS G12D 3. With central nervous system metastasis 4. Uncontrolled fluid accumulation 5. Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment 6. Concomitant clinically significant cardiovascular disease 7. Concurrent major acute or chronic infectious disease 8. 4\. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study; 9. History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse 10. Other situations not suitable for the study judged by the investigator

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Conditions

The condition(s) this trial relates to.

exocrine pancreatic carcinoma malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer Pancreatic carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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