Pancreatic CancerPhase 3RASolute 303NCT07491445
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
A Phase 3 study testing daraxonrasib, gemcitabine and nab-paclitaxel in people with Pancreatic Cancer and Pancreatic Cancer Metastatic, run by Revolution Medicines, Inc. at 82 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC
- What is being tested?
- daraxonrasib, gemcitabine and nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 82 sitesin 16 countries
- Study dates
- 9 Mar 2026to Mar 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
82 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
82 sites in 16 countries
United States21 sites
- Active, not recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
- Active, not recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Active, not recruiting
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45219
- Active, not recruiting
SCRI - Texas Oncology Dallas
Dallas, Texas, 95246
- Active, not recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Active, not recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Active, not recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Active, not recruiting
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
- Active, not recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Active, not recruiting
Mayo Clinic Cancer Center- Florida
Jacksonville, Florida, 32224
- Active, not recruiting
University of California Los Angeles Health - Hematology/Oncology
Los Angeles, California, 90095
- Active, not recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
- Active, not recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Active, not recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Active, not recruiting
Mayo Clinic - Scottsdale
Phoenix, Arizona, 85054
- Active, not recruiting
Mayo Clinic Cancer Center- Rochester
Rochester, Minnesota, 55905
- Active, not recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Active, not recruiting
University of California San Francisco
San Francisco, California, 94158
- Active, not recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258
- Active, not recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
- Active, not recruiting
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United Kingdom11 sites, 11 recruiting
- Recruiting
Queen Elizabeth Hospital - Birmingham
Birmingham, B15 2TH
- Recruiting
NHS Cambridge of Addenbrooke Hospital
Cambridge, CB2 0QQ
- Recruiting
The Clatterbridge Cancer Centre
Liverpool, L7 8YA
- Recruiting
Barts Hospital
London, EC1A 7BE
- Recruiting
Royal Free Hospital
London, NW3 2QG
- Recruiting
Guy's Hospital
London, SE1 9RT
Debashis Sarker, gstt.giresearchteam@nhs.net
- Recruiting
Royal Marsden Hospital - London
London, SW3 6JJ
- Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
SCRI Referrals Team, 02032195200 ext 65218, Referrals.SCRI@hcahealthcare.co.uk
- Recruiting
University College London Hospital
London, WC1E 6AG
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
- Recruiting
Torbay Hospital
Torquay, Devon, TQ2 7AA
Japan10 sites, 10 recruiting
- Recruiting
Chiba Cancer Center
Chiba, 260-8717
- Recruiting
NHO Kyushu Cancer Center
Fukuoka, 811-1395
Terumasa Hisano, +81-92-541-3231
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
- Recruiting
Kanagawa Cancer Canter
Kanagawa, 241-0815
Makoto Ueno, +81-45-520-2222
- Recruiting
National Cancer Center - East
Kashiwa, Chiba, 277-8577
Masafumi Ikeda, +81-4-7133-1111
- Recruiting
Cancer Institute Hospital - Japan Foundation for Cancer Research
Koto-Ku, Tokyo, 135-8550
Masato Ozaka, +81-3-3520-0111
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
- Recruiting
National Cancer Center - Tokyo
Tokyo, 104-0045
- Recruiting
Wakayama Medical University Hospital
Wakayama, 641-8510
Reiko Ashida, +81-73-447-2300
- Recruiting
Yamaguchi University Hospital
Yamaguchi, 755-8505
Tatsuya Ioka, +81-836-22-2111
Australia6 sites, 6 recruiting
- Recruiting
Epworth HealthCare
East Melbourne, Victoria, 3002
Ashleigh Poh, 613-942-68880, eh-pancreaticcentre@epworth.org.au
- Recruiting
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
Heidelberg, Victoria, 3084
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
- Recruiting
St. George Hospital
Kogarah, New South Wales, 2217
- Recruiting
Prince of Wales Hospital
Randwick, New South Wales, 2031
Kaye Kongrak, 612-938-25131, kamonwan.kongrak@health.nsw.gov.au
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Kerrie Cornall, +61 401 443 282, kerrie.cornall@health.nsw.gov.au
South Korea6 sites, 6 recruiting
- Recruiting
Dong-A University Hospital
Busan, 49201
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, Republic of Korea, 41404
- Recruiting
Seoul National University Hospital
Seoul, 03080
Eunjung Kim, miwansung@snu.ac.kr
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center - PPDS
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
Hyangsuk Jeong, 82-2-3410-955, hyangsuk.jeong@samsung.com
Italy5 sites, 5 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, 35128
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
- Recruiting
Azienda Ospedaliera Card. G. Panico
Tricase, 73039
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, 37134
Taiwan5 sites, 5 recruiting
- Recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Recruiting
China Medical University Hospital
Taichung, 40447
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Taipei, 100225, R.O.C
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Spain4 sites, 4 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28009
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario La Paz - PPDS
Madrid, 28064
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Canada3 sites, 3 recruiting
- Recruiting
McGill University - Dept. Oncology Clinical Research Program
Montreal, Quebec, H4A 3J1
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
Belgium2 sites, 2 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
- Recruiting
UZ Leuven (Univ Ziekenhuis Leuven)
Leuven, 3000
Brazil2 sites, 2 recruiting
- Recruiting
CEPON - Centro de Pesquisa Oncologicas de Santa Catarina
Florianópolis, Santa Catarina, 88034-000
Victor Fonseca, contatopesquisa@cepon.org.br
- Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
São Paulo, 09060-650
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Marjolein Yvonne Veronique Homs, +31 (0)10 704 17 54, m.homs@erasmusmc.nl
- Recruiting
St. Antonius Ziekenhuis
Utrecht, 3543 AZ
Geert Anne Cirkel, +31 (0)88-3206273, g.cirkel@antoniusziekenhuis.nl
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Lee Jie Xin Joycelyn, 6564368000, clinical.trials@nccs.com.sg
- Recruiting
Curie Oncology Pte Ltd
Singapore, 217562
Hui Shan Chong, 659 829-7005, huishan_chong@curieresearch.sg
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus der Barmherzigen Brüder Wien-Klinisch wissenschaftliche Studien
Vienna, 1020
Germany1 site, 1 recruiting
- Recruiting
Klinikum der Universitaet Muenchen Campus Grosshadern
München, 81377
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, Sha Tin
About this study
Official 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
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.
Read the detailed description
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).
- Conditions
- Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Adenocarcinoma Metastatic
- Being tested
- daraxonrasib, gemcitabine, nab-paclitaxel
- Keywords
- Pancreatic Cancer, PDAC, Pancreatic Ductal Adenocarcinoma, RAS, KRAS, NRAS, HRAS, RAS Wild-Type, RAS Mutation, Pancreatic Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenosquamous Carcinoma, Pancreatic Adenocarcinoma
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daraxonrasibDrug
oral tablets
gemcitabineDrug
intravenous (IV) infusion
nab-paclitaxelDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: daraxonrasib | Experimental | study drug Receives: Drug: daraxonrasib |
| Arm B: daraxonrasib + gemcitabine and nab-paclitaxel | Experimental | study drug in combination with chemotherapy Receives: Drug: daraxonrasib; Drug: gemcitabine; Drug: nab-paclitaxel |
| Arm C: gemcitabine and nab-paclitaxel | Active comparator | SOC chemotherapy Receives: Drug: gemcitabine; Drug: nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 2 years
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
Measured: Up to approximately 2 years
Secondary outcomes (8)
Objective response rate (ORR)
Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator.
Measured: Up to approximately 2 years
Duration of response (DOR)
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.
Measured: Up to approximately 2 years
Concentration of daraxonrasib in Arm A and B
Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits.
Measured: 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)
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.
Measured: 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)
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.
Measured: Up to approximately 2 years
Incidence of adverse events (AEs)
Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Measured: Up to approximately 2 years
Changes in vital signs
Number of patients with clinically significant changes in vital signs
Measured: Up to approximately 2 years
Changes in clinical laboratory test values
Number of patients with changes from baseline in clinical laboratory test values
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start9 Mar 2026
- Primary completionJun 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Revolution Medicines, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Revolution Medicines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491445
- Sponsor's protocol ID
- RMC-6236-303
- Acronym
- RASolute 303
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available