Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07491445

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Recruiting

Interested in participating?

Request Info

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 Adenocarcinoma Pancreatic Adenocarcinoma Metastatic Pancreatic Adenosquamous Carcinoma Pancreatic Cancer Metastatic Pancreatic Diseases Pancreatic Ductal Adenocarcinoma (PDAC) Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Calvary Mater Newcastle, Waratah, New South Wales, Australia

Loading trial locations.

About this study

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.

Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).

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 or cytologically confirmed pancreatic adenocarcinoma.
  • Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
  • Documented RAS mutation status, either mutant or wild-type.
  • 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 metastatic setting or prior RAS-targeted therapy in any treatment setting.
  • 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.

Treatment and study plan

daraxonrasib

Drug

oral tablets

Gemcitabine

Drug

intravenous (IV) infusion

Nab-paclitaxel

Drug

IV infusion

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: Up to approximately 2 years

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

  2. Overall survival (OS)

    Time frame: Up to approximately 2 years

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

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to approximately 2 years

    Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator.

  2. Duration of response (DOR)

    Time frame: Up to approximately 2 years

    DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator.

  3. Concentration of daraxonrasib in Arm A and B

    Time frame: Up to Cycle 5 Day 1 (each cycle is 28 days)

    Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits.

  4. Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26)

    Time frame: Up to approximately 2 years

    EORTC QLQ-PAN26 consists of 26 items assessing patient-reported health-related quality of life, including symptoms and impacts. Change from baseline in the pain subscale scores will be evaluated, with higher scores indicating greater symptom burden.

  5. Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Time frame: Up to approximately 2 years

    EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. Change from baseline in EORTC QLQ-C30 global health status will be assessed, with higher scores reflecting better functioning.

  6. Incidence of adverse events (AEs)

    Time frame: Up to approximately 2 years

    Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5

  7. Changes in vital signs

    Time frame: Up to approximately 2 years

    Number of patients with clinically significant changes in vital signs

  8. Changes in clinical laboratory test values

    Time frame: Up to approximately 2 years

    Number of patients with changes from baseline in clinical laboratory test values

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 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma

Acronym: RASolute 303

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 24, 2026
Registry last updated
Jul 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.