Recruiting

RASolute 303Daraxonrasib Monotherapy or in Combination for Metastatic Pancreatic Adenocarcinoma

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Study Aim

This study aims to evaluate the effectiveness of Daraxonrasib monotherapy or in combination for metastatic pancreatic adenocarcinoma by observing overall survival and progression free survival.

What is being tested

daraxonrasib

+ gemcitabine

+ nab-paclitaxel

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorRevolution Medicines, Inc.
Study ContactRevolution Medicines Study Director
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 9, 2026

Actual date on which the first participant was enrolled.

This study focuses on treating metastatic pancreatic adenocarcinoma, a type of cancer that has spread from the pancreas to other parts of the body. The main goal is to test if a drug called daraxonrasib, used alone or in combination with gemcitabine and nab-paclitaxel, can improve survival rates compared to the standard treatment of gemcitabine and nab-paclitaxel. This research is important as it aims to find better treatment options for this serious condition, potentially improving the care and life expectancy of affected patients. Participants in this study are randomly assigned to one of three groups. The first group receives daraxonrasib only, the second group receives daraxonrasib plus gemcitabine and nab-paclitaxel, and the third group receives the standard treatment of gemcitabine and nab-paclitaxel. The study measures the effectiveness of these treatments by looking at overall survival, which is the time from the start of the study until death from any cause, and progression-free survival, which is the time until the disease worsens or death occurs. The study uses established criteria to assess the progression of the disease.

Official TitleRASolute 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
Principal SponsorRevolution Medicines, Inc.
Study ContactRevolution Medicines Study Director
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

900 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

Criteria

8 inclusion criteria required to participate
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

Show More Criteria

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
study drug

Group II

Experimental
study drug in combination with chemotherapy

Group III

Active Comparator
SOC chemotherapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Comprehensive Cancer Centers of Nevada

Henderson, United StatesOpen Comprehensive Cancer Centers of Nevada in Google Maps
Recruiting

Taylor Cancer Research Center

Maumee, United States
Recruiting
2 Study Centers
RASolute 303 | Daraxonrasib Monotherapy or in Combination for Metastatic Pancreatic Adenocarcinoma | PatLynk