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Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
NCT06128551 · Revolution Medicines, Inc.
In plain English
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Official title
Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors
About this study
This is an open-label, multicenter, Phase 1b/2 study evaluating elironrasib and daraxonrasib, administered as monotherapy and in combination, in patients with advanced KRAS G12C-mutated solid tumors to determine the maximum tolerated dose (MTD), identify the recommended Phase 2 dose and schedule (RP2DS), and preliminarily assess antitumor activity.
The study includes a Phase 1b dose escalation and expansion of combination therapy, followed by a Phase 2 evaluation of the selected RP2DS as monotherapy and combination therapy to further assess safety and antitumor activity.
Eligibility criteria
Inclusion Criteria:
* 18 years of age
* Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
1. Phase 1b Dose Escalation: solid tumors, previously treated
2. Phase 1b Dose Expansion and Phase 2:
i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
* ECOG performance status 0 or 1
* Adequate organ function
Exclusion Criteria:
* Primary central nervous system (CNS) tumors
* Active brain metastases
* Known impairment of GI function that would alter the absorption
* Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
Study design
Enrollment target: 534 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-11-14
Estimated completion: 2029-06
Last updated: 2026-02-10
Interventions
Drug: ElironrasibDrug: Daraxonrasib
Primary outcomes
- • Number of patients with adverse events (AEs) in Phase 1b (Up to approximately 3 years)
- • Changes in vital signs in Phase 1b (Up to approximately 3 years)
- • Changes in clinical laboratory test values in Phase 1b (Up to approximately 3 years)
Sponsor
Revolution Medicines, Inc. · industry
Contacts & investigators
ContactRevolution Medicines, Inc. · contact · medinfo@revmed.com · 1-844-2-REVMED
InvestigatorRevolution Medicines, Inc. · study_director, Revolution Medicines, Inc.
All locations (53)
City of HopeWithdrawn
Duarte, California, United States
UC IRVINE HealthRecruiting
Orange, California, United States
UC Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
Stanford Cancer InstituteRecruiting
Stanford, California, United States
University of Colorado Cancer CenterRecruiting
Aurora, Colorado, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Moffitt Cancer Center and Research InstituteRecruiting
Tampa, Florida, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford CancerRecruiting
Detroit, Michigan, United States
START MidwestRecruiting
Grand Rapids, Michigan, United States
Columbia UniversityRecruiting
New York, New York, United States
NYU Langone HealthRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
University of OklahomaRecruiting
Oklahoma City, Oklahoma, United States
Sarah Cannon Research InstitueRecruiting
Nashville, Tennessee, United States
Mary Crowley Cancer ResearchCompleted
Dallas, Texas, United States
MD AndersonRecruiting
Houston, Texas, United States
NEXT DallasRecruiting
Irving, Texas, United States
NEXT Oncology San AntonioRecruiting
San Antonio, Texas, United States
START TexasRecruiting
San Antonio, Texas, United States
NEXT Oncology VirginiaRecruiting
Fairfax, Virginia, United States
West Cancer InstituteRecruiting
Angers, France
Institut BergonieRecruiting
Bordeaux, France
Hospital Louise PradelRecruiting
Bron, France
Oscar Lambret Center of LillleRecruiting
Lille, France
Centre Leon BerardRecruiting
Lyon, France
Cancer Institute of MontpellierRecruiting
Montpellier, France
CHU NantesRecruiting
Nantes, France
Institute of Cancer of StrasbourgWithdrawn
Strasbourg, France
Universitäts Klinikum KölnRecruiting
Cologne, Germany
Klinikum Esslingen GmbHRecruiting
Esslingen am Neckar, Germany
Krankenhaus Bethanien MoersRecruiting
Moers, Germany
Klinkum Nurnberg Paracelsus Medical UnviersityRecruiting
Nuremberg, Germany
Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle MarcheRecruiting
Ancona, Italy
Centro Di Riferimento OncologicoRecruiting
Aviano, Italy
Institute Romagnolo per lo Studio TumoriRecruiting
Meldola, Italy
Niguarda Cancer CenterRecruiting
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"Recruiting
Naples, Italy
San Luigi HospitalRecruiting
Orbassano, Italy
AUSL Romagna - S.M. delle Croci HospitalRecruiting
Ravenna, Italy
Netherlands Cancer Institute Antoni van LeeuwenhoekRecruiting
Amsterdam, Netherlands
Pan American Center for Oncology TrialsRecruiting
San Juan, Puerto Rico
START Barcelona - Hospital HM Nou DelfosRecruiting
Barcelona, Spain
Institut Catala d'Oncologia HospitalRecruiting
Barcelona, Spain
University Clinic of NavarraRecruiting
Madrid, Spain
Fundacion MD Anderson Cancer CenterRecruiting
Madrid, Spain
START MadridRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
NEXT Oncology - Quirónsalud Madrid University HospitalRecruiting
Madrid, Spain
University Clinic of NavarraRecruiting
Pamplona, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
La Fe University and Polytechnic HospitalRecruiting
Valencia, Spain
Hospital Universitario Miguel ServetRecruiting
Zaragoza, Spain