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Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06128551•Revolution Medicines, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (53)

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

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Cancer

Detroit, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

Key Dates

Start Date

November 14, 2023

Primary Completion Date

December 1, 2028

Completion Date

June 1, 2029

Last Updated

February 10, 2026

Enrollment

534

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer (NSCLC)Colorectal CancerPancreatic Ductal Adenocarcinoma

Interventions

Elironrasib

DRUG

Daraxonrasib

DRUG

Contacts

Revolution Medicines, Inc.

CONTACT

1-844-2-REVMED medinfo@revmed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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