NCT06128551RecruitingPhase 1/2
Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 534 (estimated)
- First submitted
- 7 Nov 2023
- Start date
- 14 Nov 2023
- Primary completion date
- Dec 2028
- Lead sponsor
- Revolution Medicines, Inc.
- Diseases
- Endometrial cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT06128551
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 534
- From 14 Nov 2023 to the primary completion date, Dec 2028
- 56 sites in 7 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
- Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
Other illness
- Known impairment of GI function that would alter the absorption
Other
- Primary central nervous system (CNS) tumors
- Active brain metastases
Who the study is looking for
- 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:
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitäts Klinikum Köln Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Recruiting |
| Krankenhaus Bethanien Moers Coordinator of this site? Confirm its status | Moers | Germany | Recruiting |
| Klinkum Nurnberg Paracelsus Medical Unviersity Coordinator of this site? Confirm its status | Nuremberg | Germany | Recruiting |
| START Barcelona Hospital HM Nou Delfos Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Catala d'Oncologia Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| NEXT Oncology - Quirónsalud Madrid University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Clinic of Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| START Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Fundacion MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Clinic of Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| La Fe University and Polytechnic Hospital Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| West Cancer Institute Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Hospital Louise Pradel Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Oscar Lambret Center of Lillle Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Cancer Institute of Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institute of Cancer of Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Withdrawn |
| Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Centro di Riferimento Oncologico Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Institute Romagnolo per lo Studio Tumori Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Niguarda Cancer Center Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| San Luigi Hospital Coordinator of this site? Confirm its status | Orbassano | Italy | Recruiting |
| AUSL Romagna - S.M. delle Croci Hospital Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| Centro Ricerche Cliniche di Verona Srl Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Netherlands Cancer Institute-Antoni van Leeuwenhoek Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Pan American Center for Oncology Trials Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| University of Colorado Cancer Center Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Mary Crowley Cancer Research Coordinator of this site? Confirm its status | Dallas | United States | Completed |
| Henry Ford Cancer Coordinator of this site? Confirm its status | Detroit | United States | Withdrawn |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Withdrawn |
| NEXT Oncology- Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Community Health Network Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| NEXT Dallas Coordinator of this site? Confirm its status | Irving | United States | Recruiting |
| Sarah Cannon Research Institue Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| UC Irvine Health Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Allegheny Health Network Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UC Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| START Texas Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| NEXT Oncology San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Stanford Cancer Institute Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Moffitt Cancer Center and Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.