Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
RASolute 303
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
1 other identifier
interventional
900
3 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Mar 2026
Shorter than P25 for phase_3 pancreatic-cancer
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2026
CompletedFirst Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
July 21, 2026
July 1, 2026
2.2 years
March 10, 2026
July 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression free survival (PFS)
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.
Up to approximately 2 years
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
Up to approximately 2 years
Secondary Outcomes (8)
Objective response rate (ORR)
Up to approximately 2 years
Duration of response (DOR)
Up to approximately 2 years
Concentration of daraxonrasib in Arm A and B
Up to Cycle 5 Day 1 (each cycle is 28 days)
Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26)
Up to approximately 2 years
Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Up to approximately 2 years
- +3 more secondary outcomes
Study Arms (3)
Arm A: daraxonrasib
EXPERIMENTALstudy drug
Arm B: daraxonrasib + gemcitabine and nab-paclitaxel
EXPERIMENTALstudy drug in combination with chemotherapy
Arm C: gemcitabine and nab-paclitaxel
ACTIVE COMPARATORSOC chemotherapy
Interventions
intravenous (IV) infusion
IV infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Honor Health Research Institute
Scottsdale, Arizona, 85258, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45219, United States
Taylor Cancer Research Center
Maumee, Ohio, 43537, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
SCRI - Texas Oncology Dallas
Dallas, Texas, 95246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
National Cancer Center - East
Kashiwa, Chiba, 277-8577, Japan
Cancer Institute Hospital - Japan Foundation for Cancer Research
Koto-Ku, Tokyo, 135-8550, Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kanagawa Cancer Canter
Kanagawa, 241-0815, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Yamaguchi University Hospital
Yamaguchi, 755-8505, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 24, 2026
Study Start
March 9, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
July 21, 2026
Record last verified: 2026-07