Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?
NCT ID NCT07805954
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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- AI takes aim at pancreatic cancer: can it forecast chemotherapy outcomes?
- Can a triple therapy shrink pancreatic tumors enough for complete surgery?