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RecruitingNCT07252232RASolute 304Updated Oct 23, 2026

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

A Phase 3 interventional study of daraxonrasib in Pancreatic Cancer, PDAC and PDAC - Pancreatic Ductal Adenocarcinoma, sponsored by Revolution Medicines, Inc.. Recruiting at 86 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Revolution Medicines, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Updated Oct 23, 2026First site in Canada8 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Read the detailed description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.

02

Conditions studied

  • Pancreatic Cancer
  • PDAC
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Resectable Pancreatic Ductal Adenocarcinoma (PDAC)
  • Resected Pancreatic Adenocarcinoma

Keywords

  • Pancreatic Cancer
  • PDAC
  • Pancreatic Ductal Adenocarcinoma
  • RAS
  • KRAS
  • NRAS
  • HRAS
  • RAS Wild-Type
  • RASolute
  • Resectable Pancreatic Ductal Adenocarcinoma
  • Resectable PDAC
  • Resected Pancreatic Adenocarcinoma
  • RAS Mutation
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 500 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Revolution Medicines, Inc. is the lead sponsor of 20 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At least 18 years old and has provided .
  • (ECOG) performance status of 0 or 1.
  • confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or disease.
  • Must have received perioperative (, adjuvant, or a combination of both) multi-agent chemotherapy.
  • Must have completed most recent treatment within the past 12 weeks.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Documented RAS mutation status.
  • Able to take oral medications.

Exclusion criteria

Exclusion Criteria:

  • Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    daraxonrasib

    study drug

    Drug: daraxonrasib

  • No intervention
    SOC Observation

    Patients randomized to the comparator control arm will receive SOC observation.

Interventions

06

What researchers measure

Primary outcomes

  1. Disease-Free Survival (DFS) per Investigator

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

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Overall survival (OS)

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

    Time frame: Up to approximately 5 years

  2. DFS per blinded independent central review (BICR)

    DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR.

    Time frame: Up to approximately 5 years

  3. DFS Rate at 1 year and 2 years

    DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively.

    Time frame: Up to approximately 2 years

  4. OS rate at 1 year and 2 years

    OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively.

    Time frame: Up to approximately 2 years

  5. Safety and tolerability of daraxonrasib

    Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests.

    Time frame: Up to approximately 5 years

  6. Pharmacokinetics (PK)

    Predose concentration of daraxonrasib

    Time frame: Up to Cycle 4 Day 1 (Day 85)

07

Study locations

85 of 86 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
8 sites added — first site in Canada
Show 8 added (3 United States, 2 Canada, 1 Germany, 1 Italy, 1 Spain)
  • The University of Alabama at Birmingham · Birmingham, United States
  • Mount Sinai Braman Comprehensive Cancer Center · Miami Beach, United States
  • Rutgers Cancer Institute · New Brunswick, United States
  • Princess Margaret Cancer Centre - University Health Network · Toronto, Canada
  • McGill University Health Centre · Montreal, Canada
  • Universitaetsklinikum Ulm · Ulm, Germany
  • Azienda Ospedaliera Universitaria-Luigi Vanvitelli · Naples, Italy
  • Hospital Universitario Miguel Servet · Zaragoza, Spain
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    8 sites added — first site in Canada
    Show 8 added (3 United States, 2 Canada, 1 Germany, 1 Italy, 1 Spain)
    • The University of Alabama at Birmingham · Birmingham, United States
    • Mount Sinai Braman Comprehensive Cancer Center · Miami Beach, United States
    • Rutgers Cancer Institute · New Brunswick, United States
    • Princess Margaret Cancer Centre - University Health Network · Toronto, Canada
    • McGill University Health Centre · Montreal, Canada
    • Universitaetsklinikum Ulm · Ulm, Germany
    • Azienda Ospedaliera Universitaria-Luigi Vanvitelli · Naples, Italy
    • Hospital Universitario Miguel Servet · Zaragoza, Spain

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07252232
Responsible party
Sponsor
First posted
Nov 26, 2025
Start date
Dec 15, 2025
Primary completion
May 10, 2029 (estimated)
Completion
Jul 10, 2030 (estimated)
Last update
Oct 23, 2026

Study contacts

Revolution Medicines Study Director
Contact
medinfo@revmed.com
1-844-2-REVMED

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Daraxonrasib

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