NCT07491445RecruitingPhase 3
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- 9 Mar 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Revolution Medicines, Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT07491445
- EU CT number
- 2025-525088-34-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 900
- From 9 Mar 2026 to the primary completion date, 30 Jun 2028
- 137 sites in 21 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
- Major surgery within 28 days prior to randomization.
Other illness
- Active or known history of untreated central nervous system metastatic disease.
- Any conditions that may affect the ability to take or absorb study drug.
Other
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (137)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Oberoesterreichische Gesundheitsholding GmbH Coordinator of this site? Confirm its status | Steyr | Austria | Recruiting |
| Krankenhaus Der Barmherzigen Brueder Wien Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Epworth Healthcare Coordinator of this site? Confirm its status | East Melbourne | Australia | Recruiting |
| Austin Health, Olivia Newton-John Cancer Research & Wellness Centre Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Herston | Australia | Recruiting |
| St George Hospital Coordinator of this site? Confirm its status | Kogarah | Australia | Recruiting |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Recruiting |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Recruiting |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Imelda Coordinator of this site? Confirm its status | Bonheiden | Belgium | Recruiting |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| CEPON - Centro de Pesquisa Oncologicas de Santa Catarina Coordinator of this site? Confirm its status | Florianópolis | Brazil | Recruiting |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| McGill University - Dept. Oncology Clinical Research Program Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Sana Kliniken Berlin-Brandenburg GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Klinikum München-Bogenhausen Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Klinikum rechts der Isar der Technischen Universität München Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Klinikum der Ludwigs-Maximilians-Universität München, Campus Großhadern Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Withdrawn |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Withdrawn |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Withdrawn |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Withdrawn |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Withdrawn |
| CARIO Centre Armoricain de Radiotherapie d'Imagerie medicale et d'Oncologie Coordinator of this site? Confirm its status | Plerin | France | Withdrawn |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Withdrawn |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Withdrawn |
| Hopital Paul Brousse Coordinator of this site? Confirm its status | Villejuif Cedex | France | Withdrawn |
| Queen Elizabeth Hospital Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| NHS Cambridge of Addenbrooke Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| The Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| Sarah Cannon Research Institute UK Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Barts Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Marsden Hospital - London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Torbay Hospital Coordinator of this site? Confirm its status | Torquay | United Kingdom | Recruiting |
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Pia Fondazione Di Culto E Religione Card G Panico Coordinator of this site? Confirm its status | Tricase | Italy | Recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Chiba Cancer Center Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| NHO Kyushu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Kanagawa Cancer Canter Coordinator of this site? Confirm its status | Kanagawa | Japan | Recruiting |
| National Cancer Center East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Cancer Institute Hospital - Japan Foundation for Cancer Research Coordinator of this site? Confirm its status | Koto-Ku | Japan | Recruiting |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| National Cancer Center - Tokyo Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Recruiting |
| Yamaguchi University Hospital Coordinator of this site? Confirm its status | Yamaguchi | Japan | Recruiting |
| Dong-A University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Asan Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Stichting OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| St. Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Oslo Universitetssykehus HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Pratia Onkologia Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Recruiting |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Recruiting |
| Region Kronoberg Coordinator of this site? Confirm its status | Vaxjo | Sweden | Recruiting |
| Curie Oncology Pte Ltd Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| National Cancer Centre Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Active, not recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| University of Cincinnati Cancer Center Coordinator of this site? Confirm its status | Cincinnati | United States | Active, not recruiting |
| SCRI - Texas Oncology Dallas Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Active, not recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Active, not recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Active, not recruiting |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Henderson | United States | Active, not recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Active, not recruiting |
| Mayo Clinic Cancer Center- Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Active, not recruiting |
| University of California Los Angeles Health - Hematology/Oncology Coordinator of this site? Confirm its status | Los Angeles | United States | Active, not recruiting |
| Taylor Cancer Research Center Coordinator of this site? Confirm its status | Maumee | United States | Active, not recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Active, not recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| Mayo Clinic - Scottsdale Coordinator of this site? Confirm its status | Phoenix | United States | Active, not recruiting |
| Mayo Clinic Cancer Center - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Active, not recruiting |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Active, not recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Active, not recruiting |
| Honor Health Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Active, not recruiting |
| Virginia Mason Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Active, not recruiting |
| H Lee Moffitt Cancer Center and Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.