Treating Advanced Solid Tumors with a KRAS G12C Mutation Using Targeted Therapies Called RAS(ON) Inhibitors
Treatment
Phase 1/2 treatment study for advanced colorectal, pancreatic or lung cancer with a KRAS G12C mutation
Clinicaltrials.gov identifier:NCT06128551
Study Contact Information:
For additional information, contact:
Revolution Medicines Study Director
📞 1-844-2-REVMED
📧 [email protected]
About the Study
This study is testing two new investigational targeted drugs called RAS(ON) inhibitors to learn how safe they are and how well they may work in people with advanced or solid tumors that have a called a KRAS G12C mutation.
Researchers are studying these drugs:
- On their own, and
- Together as a combination
The study is also looking at how the drugs move through the body and whether tumors shrink or stop growing.
RAS(ON) inhibitors are oral targeted therapies designed to block a pathway called RAS, which plays a role in several types of cancer. RAS(ON) inhibitors are not yet FDA‑approved and are only available through participation in a clinical trial. One RAS(ON) inhibitor, known as daraxonrasib is available for some people with advanced pancreatic cancer through a program known as . You can read more about for daraxonrasib.
This Study is Open To:
In order to participate, people must have the following:
- Diagnosed with an advanced or solid tumor that cannot be treated with surgery or radiation.
- Their cancer must have a known as a KRAS G12C mutation.
- Their cancer can be seen and measured on scans.
- They are able to take oral medication.
- They have good overall physical functioning.
See clinicaltrials.gov for full eligibility criteria.
This Study is NOT Open To:
People with any of the following cannot join the study:
- Have active or untreated spread to the brain or central nervous system.
- Have any other conditions that may affect the ability to take or absorb the study drug.
- Had major surgery within the past 4 weeks.
What the Study Involves
All participants will receive one or both of the study drugs. This is an open label study, all participants will know which study drug they received. The study will enroll in two phases.
- Phase 1 will be a dose-finding phase to determine the ideal dose.
- Phase 2 will be a dose-expansion phase once the ideal dose is determined.
Participants will be assigned to one of three groups and will receive one or both RAS(ON) inhibitors to be taken orally (by mouth) daily:
- Daraxonrasib alone
- Elironrasib alone
- Daraxonrasib and elironrasib in combination
This is an open‑label study, meaning participants and researchers know which treatments are being given. Treatment group will be determined based on:
- The study phase (dose‑finding vs dose‑expansion).
- The specific group that is currently enrolling.
- The participant’s cancer type and prior treatments.
While participants are receiving daraxonrasib, elironrasib, or both, follow‑up care includes close monitoring by the study team, such as:
- Regular clinic visits.
- Blood tests to monitor safety, organ function, and drug levels.
- Physical exams and vital signs.
- Imaging scans (such as CT or ) to see whether tumors are shrinking, staying the same or growing.
- Ongoing monitoring and management of side effects.
Participants will receive the study drugs and remain on the study as long as the drugs are helping and side effects are manageable.
Study Contact Information:
For additional information, contact:
Revolution Medicines Study Director
📞 1-844-2-REVMED
📧 [email protected]
Locations:
California
City: Orange RECRUITING
Facility: UC IRVINE Health
Contact Info:
No contact info provided
City: Sacramento RECRUITING
Facility: UC Davis Comprehensive Cancer Center
Contact Info:
No contact info provided
City: Stanford RECRUITING
Facility: Stanford Cancer Institute
Contact Info:
No contact info provided
Colorado
City: Aurora RECRUITING
Facility: University of Colorado Cancer Center
Contact Info:
No contact info provided
Florida
City: Sarasota RECRUITING
Facility: Florida Cancer Specialists
Contact Info:
No contact info provided
City: Tampa RECRUITING
Facility: Moffitt Cancer Center and Research Institute
Contact Info:
No contact info provided
Massachusetts
City: Boston RECRUITING
Facility: Dana Farber Cancer Institute
Contact Info:
No contact info provided
Michigan
City: Grand Rapids RECRUITING
Facility: START Midwest
Contact Info:
No contact info provided
New York
City: New York RECRUITING
Facility: Columbia University
Contact Info:
No contact info provided
City: New York RECRUITING
Facility: NYU Langone Health
Contact Info:
No contact info provided
City: New York RECRUITING
Facility: Memorial Sloan Kettering Cancer Center
Contact Info:
No contact info provided
Oklahoma
City: Oklahoma City RECRUITING
Facility: University of Oklahoma
Contact Info:
No contact info provided
Tennessee
City: Nashville RECRUITING
Facility: Sarah Cannon Research Institue
Contact Info:
No contact info provided
Texas
City: Houston RECRUITING
Facility: MD Anderson
Contact Info:
No contact info provided
City: Irving RECRUITING
Facility: NEXT Dallas
Contact Info:
No contact info provided
City: San Antonio RECRUITING
Facility: START Texas
Contact Info:
No contact info provided
City: San Antonio RECRUITING
Facility: NEXT Oncology San Antonio
Contact Info:
No contact info provided
Virginia
City: Fairfax RECRUITING
Facility: NEXT Oncology Virginia
Contact Info:
No contact info provided
Puerto Rico
City: San Juan RECRUITING
Facility: Pan American Center for Oncology Trials
Contact Info:
No contact info provided
Other Countries
Country: France
City: Angers RECRUITING
Facility: West Cancer Institute
Contact Info:
No contact info provided
Country: France
City: Bordeaux RECRUITING
Facility: Institut Bergonie
Contact Info:
No contact info provided
Country: France
City: Bron RECRUITING
Facility: Hospital Louise Pradel
Contact Info:
No contact info provided
Country: France
City: Lille RECRUITING
Facility: Oscar Lambret Center of Lillle
Contact Info:
No contact info provided
Country: France
City: Lyon RECRUITING
Facility: Centre Leon Berard
Contact Info:
No contact info provided
Country: France
City: Montpellier RECRUITING
Facility: Cancer Institute of Montpellier
Contact Info:
No contact info provided
Country: France
City: Nantes RECRUITING
Facility: CHU Nantes
Contact Info:
No contact info provided
Country: Germany
City: Cologne RECRUITING
Facility: Universitäts Klinikum Köln
Contact Info:
No contact info provided
Country: Germany
City: Esslingen am Neckar RECRUITING
Facility: Klinikum Esslingen GmbH
Contact Info:
No contact info provided
Country: Germany
City: Moers RECRUITING
Facility: Krankenhaus Bethanien Moers
Contact Info:
No contact info provided
Country: Germany
City: Nuremberg RECRUITING
Facility: Klinkum Nurnberg Paracelsus Medical Unviersity
Contact Info:
No contact info provided
Country: Italy
City: Ancona RECRUITING
Facility: Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche
Contact Info:
No contact info provided
Country: Italy
City: Aviano RECRUITING
Facility: Centro Di Riferimento Oncologico
Contact Info:
No contact info provided
Country: Italy
City: Meldola RECRUITING
Facility: Institute Romagnolo per lo Studio Tumori
Contact Info:
No contact info provided
Country: Italy
City: Milan RECRUITING
Facility: Niguarda Cancer Center
Contact Info:
No contact info provided
Country: Italy
City: Naples RECRUITING
Facility: Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
Contact Info:
No contact info provided
Country: Italy
City: Orbassano RECRUITING
Facility: San Luigi Hospital
Contact Info:
No contact info provided
Country: Italy
City: Ravenna RECRUITING
Facility: AUSL Romagna - S.M. delle Croci Hospital
Contact Info:
No contact info provided
Country: Netherlands
City: Amsterdam RECRUITING
Facility: Netherlands Cancer Institute Antoni van Leeuwenhoek
Contact Info:
No contact info provided
Country: Spain
City: Barcelona RECRUITING
Facility: START Barcelona - Hospital HM Nou Delfos
Contact Info:
No contact info provided
Country: Spain
City: Barcelona RECRUITING
Facility: Institut Catala d'Oncologia Hospital
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: University Clinic of Navarra
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Fundacion MD Anderson Cancer Center
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: START Madrid
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Hospital Universitario 12 de Octubre
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: NEXT Oncology - Quirónsalud Madrid University Hospital
Contact Info:
No contact info provided
Country: Spain
City: Pamplona RECRUITING
Facility: University Clinic of Navarra
Contact Info:
No contact info provided
Country: Spain
City: Seville RECRUITING
Facility: Hospital Universitario Virgen Macarena
Contact Info:
No contact info provided
Country: Spain
City: Valencia RECRUITING
Facility: La Fe University and Polytechnic Hospital
Contact Info:
No contact info provided
Country: Spain
City: Zaragoza RECRUITING
Facility: Hospital Universitario Miguel Servet
Contact Info:
No contact info provided
Treatment
Phase 1/2 treatment study for advanced colorectal, pancreatic or lung cancer with a KRAS G12C mutation
Clinicaltrials.gov identifier:NCT06128551
Study Contact Information:
For additional information, contact:
Revolution Medicines Study Director
📞 1-844-2-REVMED
📧 [email protected]