New hope for hard-to-treat pancreatic cancer: targeted drug combo enters phase 3 trial
NCT ID NCT07621718
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 7 times
Summary
This study tests whether adding an experimental drug called zoldonrasib to standard chemotherapy helps people with a specific genetic form of metastatic pancreatic cancer (KRAS G12D mutation) live longer without their cancer growing. About 670 adults with advanced pancreatic cancer that has spread will receive either the drug combo or a placebo plus chemo. The goal is to see if the targeted therapy improves survival and slows disease progression.
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 670 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 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 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. * Diagnosis of metastatic disease ≤ 6 weeks prior to screening. * Documented KRAS G12D mutation status. * Measurable disease per RECIST v1.1. * Adequate organ function (bone marrow, liver, kidney, coagulation). * Able to take oral medications. Exclusion Criteria: * Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting. * Prior systemic RAS-targeted therapy any time prior to randomization. * Presence of other known driver mutations with approved targeted therapies * Active or known history of untreated central nervous system metastatic 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic KRAS G12D-mutated pancreatic adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
9 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Astera Cancer Care
RECRUITINGEast Brunswick, New Jersey, 08816, United States
-
Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
-
Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21287, United States
Contact Email: •••••@•••••
-
Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
-
Piedmont Healthcare
RECRUITINGAtlanta, Georgia, 30318, United States
-
Rutgers Cancer University
RECRUITINGNew Brunswick, New Jersey, 08901, United States
-
The University of Arizona Cancer Center-North Campus
RECRUITINGTucson, Arizona, 85719, United States
-
University of Chicago Medical Center
RECRUITINGChicago, Illinois, 60637, United States
-
Yale University
RECRUITINGNew Haven, Connecticut, 06511, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple attack on pancreatic tumors: can radiation and immunotherapy make inoperable cancer operable?
- Can a blood test before pancreatic surgery predict a dangerous leak?
- New chemo cocktail targets pancreatic cancer at every stage
- Bacteria-Based immunotherapy targets pancreatic tumors in first human test
- Old antiparasitic drug joins chemo in pancreatic cancer fight
- Can a new radiation machine cut breath holds for cancer patients?