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Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Elironrasib (drug)
Daraxonrasib (drug)

Sponsor: Revolution Medicines, Inc. · Participants: 534 · Started: Nov 14, 2023

Contact the study team

Revolution Medicines, Inc. · Phone: 1-844-2-REVMED

Official record on ClinicalTrials.gov — NCT06128551

Locations in the U.S.

California	UC IRVINE Health, Orange UC Davis Comprehensive Cancer Center, Sacramento Stanford Cancer Institute, Stanford
Colorado	University of Colorado Cancer Center, Aurora
Florida	Florida Cancer Specialists, Sarasota Moffitt Cancer Center and Research Institute, Tampa
Indiana	Community Health Network, Indianapolis
Massachusetts	Dana Farber Cancer Institute, Boston
Michigan	START Midwest, Grand Rapids
New York	Columbia University, New York Memorial Sloan Kettering Cancer Center, New York NYU Langone Health, New York
Oklahoma	University of Oklahoma, Oklahoma City
Pennsylvania	Allegheny Health Network, Pittsburgh
Tennessee	Sarah Cannon Research Institue, Nashville
Texas	MD Anderson, Houston NEXT Dallas, Irving NEXT Oncology San Antonio, San Antonio START Texas, San Antonio
Virginia	NEXT Oncology Virginia, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.