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Study of Zoldonrasib for Metastatic Pancreatic Cancer

This study is testing a new treatment called zoldonrasib in combination with standard chemotherapy for people with metastatic pancreatic cancer. Metastatic means the cancer has spread to other parts of the body. You may be able to join if your pancreatic cancer has a specific change in the KRAS gene, called KRAS G12D. Researchers want to see if zoldonrasib plus chemotherapy can help you live longer or prevent the cancer from growing for a longer time compared to a placebo (an inactive pill) plus chemotherapy. The study plans to enroll about 670 participants.

Study design
This is a Phase 3, global study where participants are randomly assigned to receive either zoldonrasib or a placebo, both in combination with chemotherapy. It is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 4 years to measure how long they live and how long the cancer is controlled.

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NCT07621718

Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )

Recruiting
PHASE3Ages 18+InterventionalTreatment
Revolution Medicines, Inc.
~670 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:ZoldonrasibPlaceboOxaliplatinLeucovorin (Calcium Folinate)5-FluorouracilIrinotecan

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over Up to approximately 4 years
+1 more outcome measured

Conditions

Pancreatic Cancer
Pancreatic Cancer Metastatic
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Ductal Adenocarcinoma (PDAC)
Pancreatic Adenocarcinoma Metastatic
Pancreatic Adenocarcinoma
Pancreatic Adenosquamous Carcinoma

Explore related trials

Pancreatic AdenocarcinomaGTPase KRas

Where it's being run

6 sites across 6 states
Arizona1
Florida1
Georgia1
Illinois1
Maryland1
New Jersey1

Who to contact

Revolution Medicines Study Director
[email protected]
1-844-2-REVMED
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression free survival (PFS)Up to approximately 4 years

    PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by Investigator.

  • Overall survival (OS)Up to approximately 4 years

    OS is defined as the time from randomization until death from any cause.