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NCT Number: NCT07252232

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site PDAC PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms Resectable Pancreatic Ductal Adenocarcinoma (PDAC) Resected Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CRLCC Eugene Marquis, Rennes, Cedex, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
  • Must have received perioperative (neoadjuvant, 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

  • 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.

Treatment and study plan

daraxonrasib

Drug

oral tablets

Primary outcomes

  1. Disease-Free Survival (DFS) per Investigator

    Time frame: Up to approximately 5 years

    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.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to approximately 5 years

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

  2. DFS per blinded independent central review (BICR)

    Time frame: Up to approximately 5 years

    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.

  3. DFS Rate at 1 year and 2 years

    Time frame: Up to approximately 2 years

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

  4. OS rate at 1 year and 2 years

    Time frame: Up to approximately 2 years

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

  5. Safety and tolerability of daraxonrasib

    Time frame: Up to approximately 5 years

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

  6. Pharmacokinetics (PK)

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

    Predose concentration of daraxonrasib

Study contacts

Contact information is provided by the study sponsor or research team.

Revolution Medicines Study Director

CONTACT

[email protected]

1-844-2-REVMED

Sponsors and collaborators

Lead sponsor

Revolution Medicines, Inc.

Industry

Registry information

Official study title

RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Acronym: RASolute 304

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Nov 26, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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