Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?

NCT ID NCT07805954

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This phase 3 trial compares a combination of two experimental oral drugs, zoldonrasib and daraxonrasib, against standard chemotherapy (gemcitabine plus nab-paclitaxel) as the first treatment for people with metastatic pancreatic cancer that has a specific KRAS G12D mutation. The study enrolls about 400 adults who have not yet received treatment for advanced disease. Researchers measure how long participants live without the cancer growing and overall survival to see if the targeted pill combination works better than chemo.

What this could mean

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

Active substance
A combination of two investigational oral drugs, zoldonrasib and daraxonrasib, which target the KRAS G12D mutation driving cancer growth.
What this could lead to
If successful, this combination could offer a new first-line treatment option that is more effective and less toxic than chemotherapy for people with this specific genetic subtype of pancreatic cancer.
What could go wrong
The trial is large and randomized, but the drugs are still investigational and may not outperform chemotherapy. Side effects from the targeted pills are possible, and the benefit may only apply to the subset of patients with the KRAS G12D mutation.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

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

Started

Aug 2026

Expected to finish

Apr 2030

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 years and older

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: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed pancreatic adenocarcinoma, including adenosquamous carcinoma, not previously treated in the locally advanced unresectable or metastatic setting. * No prior treatment in the locally advanced unresectable or metastatic setting * Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent. * Documented KRAS G12D mutation status. * Measurable disease per RECIST v1.1. * Adequate organ function (bone marrow, liver, kidney, coagulation). Exclusion Criteria: * Mutation status with known driver mutations for which there are approved targeted therapies. * Acinar cell carcinoma, pancreatic neuroendocrine tumors, tumors involving islet cells or islet cell neoplasms, and other non-adenocarcinoma pancreatic malignancies. * Tumors determined to originate from non-pancreatic primary sites. * Prior treatment with MAPK-pathway targeted therapy or administration of RAS-targeted vaccine in the metastatic setting. * Active or known history of untreated central nervous system metastatic or leptomeningeal disease. * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 28 days prior to randomization. * Patient is unable or unwilling to comply with protocol-required study visits or procedures. * Additional inclusion \& exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

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