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Study of Elironrasib and Daraxonrasib for Advanced KRAS G12C Mutant Solid Tumors

This study is testing two drugs, Elironrasib and Daraxonrasib, alone and in combination, for people with advanced solid tumors that have a specific genetic change called KRAS G12C. This includes non-small cell lung cancer (NSCLC), colorectal cancer, and pancreatic cancer. The main goals are to understand the safety and how well your body handles these drugs. Researchers will also look for early signs of anti-tumor activity. To join, you must be at least 18 years old and have a KRAS G12C-mutated solid tumor that has advanced or spread and cannot be cured with current treatments. The study is currently unclear on its recruitment status, but plans to enroll 534 participants.

Study design
This is an open-label, multi-center Phase 1b/2 study. It will evaluate Elironrasib and Daraxonrasib as single treatments and in combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06128551

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Revolution Medicines, Inc.
~534 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:ElironrasibDaraxonrasib

At a glance

Recruiting sites
51 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with adverse events (AEs) in Phase 1b
Measured over Up to approximately 3 years
+5 more outcomes measured

Conditions

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

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGTPase KRas

Where it's being run

55 sites across 18 states
Spain11
France8
Italy7
Texas5
California4
Germany4
New York3
Florida2

Study leadership

  • Revolution Medicines, Inc. · STUDY_DIRECTOR · Revolution Medicines, Inc.

Who to contact

Revolution Medicines, Inc.
[email protected]
1-844-2-REVMED
Email the study team

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Eligibility criteria

Inclusion

18 years of age
Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
ECOG performance status 0 or 1
Adequate organ function

Exclusion

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

What this trial measures

  • Number of patients with adverse events (AEs) in Phase 1bUp to approximately 3 years

    Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5

  • Changes in vital signs in Phase 1bUp to approximately 3 years

    Number of patients with clinically significant changes in vital signs

  • Changes in clinical laboratory test values in Phase 1bUp to approximately 3 years

    Number of patients with clinically significant changes in clinical laboratory test values

  • Dose Limiting Toxicities in Phase 1b21 days

    Number of participants with dose limiting toxicities

  • Changes in ECGs in Phase 1bUp to approximately 3 years

    Number of patients with clinically significant changes in ECGs

  • Overall Response Rate (ORR) in Phase 2Up to approximately 3 years

    Overall response rate per RECIST v1.1 as assessed by blinded independent central review (BICR)