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
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
City of Hope
WITHDRAWN
Duarte
UC IRVINE Health
RECRUITING
Orange
UC Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Stanford Cancer Institute
RECRUITING
Stanford
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
Florida
Florida Cancer Specialists
RECRUITING
Sarasota
Moffitt Cancer Center and Research Institute
RECRUITING
Tampa
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
Henry Ford Cancer
RECRUITING
Detroit
START Midwest
RECRUITING
Grand Rapids
New York
Columbia University
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Oklahoma
University of Oklahoma
RECRUITING
Oklahoma City
Tennessee
Sarah Cannon Research Institue
RECRUITING
Nashville
Texas
Mary Crowley Cancer Research
COMPLETED
Dallas
MD Anderson
RECRUITING
Houston
NEXT Dallas
RECRUITING
Irving
NEXT Oncology San Antonio
RECRUITING
San Antonio
START Texas
RECRUITING
San Antonio
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Other Locations
France
West Cancer Institute
RECRUITING
Angers
Institut Bergonie
RECRUITING
Bordeaux
Hospital Louise Pradel
RECRUITING
Bron
Oscar Lambret Center of Lillle
RECRUITING
Lille
Centre Leon Berard
RECRUITING
Lyon
Cancer Institute of Montpellier
RECRUITING
Montpellier
CHU Nantes
RECRUITING
Nantes
Institute of Cancer of Strasbourg
WITHDRAWN
Strasbourg
Germany
Universitäts Klinikum Köln
RECRUITING
Cologne
Klinikum Esslingen GmbH
RECRUITING
Esslingen Am Neckar
Krankenhaus Bethanien Moers
RECRUITING
Moers
Klinkum Nurnberg Paracelsus Medical Unviersity
RECRUITING
Nuremberg
Italy
Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche
RECRUITING
Ancona
Centro Di Riferimento Oncologico
RECRUITING
Aviano
Institute Romagnolo per lo Studio Tumori
RECRUITING
Meldola
Niguarda Cancer Center
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
RECRUITING
Naples
San Luigi Hospital
RECRUITING
Orbassano
AUSL Romagna - S.M. delle Croci Hospital
RECRUITING
Ravenna
Netherlands
Netherlands Cancer Institute Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Puerto Rico
Pan American Center for Oncology Trials
RECRUITING
San Juan
Spain
Institut Catala d'Oncologia Hospital
RECRUITING
Barcelona
START Barcelona - Hospital HM Nou Delfos
RECRUITING
Barcelona
Fundacion MD Anderson Cancer Center
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
NEXT Oncology - Quirónsalud Madrid University Hospital
RECRUITING
Madrid
START Madrid
RECRUITING
Madrid
University Clinic of Navarra
RECRUITING
Madrid
University Clinic of Navarra
RECRUITING
Pamplona
Hospital Universitario Virgen Macarena
RECRUITING
Seville
La Fe University and Polytechnic Hospital
RECRUITING
Valencia
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Revolution Medicines, Inc.
medinfo@revmed.com
1-844-2-REVMED
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2029-06
Participants
Target number of participants: 534
Treatments
Experimental: Elironrasib Monotherapy
Phase 2 only
Experimental: Daraxonrasib Monotherapy
Phase 2 only
Experimental: Daraxonrasib + Elironrasib Combination
Phase 1b and 2
Related Therapeutic Areas
Sponsors
Leads: Revolution Medicines, Inc.