Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
Recruiting · NCT06128551 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
DaraxonrasibElironrasib
What this trial is about
This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 18 years of age
- Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
- Phase 1b Dose Escalation: solid tumors, previously treated
- 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
Where it is running
55 locations listed across 12 US states.
- City of Hope - Duarte, California, United States
- UC IRVINE Health - Orange, California, United States
- UC Davis Comprehensive Cancer Center - Sacramento, California, United States
- Stanford Cancer Institute - Stanford, California, United States
- University of Colorado Cancer Center - Aurora, Colorado, United States
- Florida Cancer Specialists - Sarasota, Florida, United States
- Moffitt Cancer Center and Research Institute - Tampa, Florida, United States
- Community Health Network - Indianapolis, Indiana, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Henry Ford Cancer - Detroit, Michigan, United States
- START Midwest - Grand Rapids, Michigan, United States
- Columbia University - New York, New York, United States
- NYU Langone Health - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- University of Oklahoma - Oklahoma City, Oklahoma, United States
- Allegheny Health Network - Pittsburgh, Pennsylvania, United States
- Sarah Cannon Research Institue - Nashville, Tennessee, United States
- Mary Crowley Cancer Research - Dallas, Texas, United States
- MD Anderson - Houston, Texas, United States
- NEXT Dallas - Irving, Texas, United States
- NEXT Oncology San Antonio - San Antonio, Texas, United States
- START Texas - San Antonio, Texas, United States
- NEXT Oncology Virginia - Fairfax, Virginia, United States
- Netherlands Cancer Institute Antoni van Leeuwenhoek - Amsterdam, Netherlands
- Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche - Ancona, Italy
- West Cancer Institute - Angers, France
- Centro Di Riferimento Oncologico - Aviano, Italy
- START Barcelona - Hospital HM Nou Delfos - Barcelona, Spain
- Institut Catala d'Oncologia Hospital - Barcelona, Spain
- Institut Bergonie - Bordeaux, France
- Hospital Louise Pradel - Bron, France
- Universitäts Klinikum Köln - Cologne, Germany
- Klinikum Esslingen GmbH - Esslingen am Neckar, Germany
- Oscar Lambret Center of Lillle - Lille, France
- Centre Leon Berard - Lyon, France
- University Clinic of Navarra - Madrid, Spain
- Fundacion MD Anderson Cancer Center - Madrid, Spain
- START Madrid - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- NEXT Oncology - Quirónsalud Madrid University Hospital - Madrid, Spain
- Institute Romagnolo per lo Studio Tumori - Meldola, Italy
- Niguarda Cancer Center - Milan, Italy
- Krankenhaus Bethanien Moers - Moers, Germany
- Cancer Institute of Montpellier - Montpellier, France
- CHU Nantes - Nantes, France
- Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" - Naples, Italy
- Klinkum Nurnberg Paracelsus Medical Unviersity - Nuremberg, Germany
- San Luigi Hospital - Orbassano, Italy
- University Clinic of Navarra - Pamplona, Spain
- AUSL Romagna - S.M. delle Croci Hospital - Ravenna, Italy
- Pan American Center for Oncology Trials - San Juan, Puerto Rico
- Hospital Universitario Virgen Macarena - Seville, Spain
- Institute of Cancer of Strasbourg - Strasbourg, France
- La Fe University and Polytechnic Hospital - Valencia, Spain
- Hospital Universitario Miguel Servet - Zaragoza, Spain