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Study of RMC-5127 for Advanced KRAS G12V-Mutant Solid Tumors

This study is testing RMC-5127, a targeted therapy, alone and in combination with either daraxonrasib or cetuximab, for adults with advanced solid tumors that have a specific genetic change called KRAS G12V. This includes certain non-small cell lung cancer, colorectal cancer, and pancreatic cancer. The main goal is to see how safe RMC-5127 is and how well people tolerate it. Researchers will also look at how the body processes the drugs and if they show any early signs of shrinking tumors. You may be able to join if you are at least 18, have an advanced KRAS G12V-mutated solid tumor, and your cancer has progressed after standard treatments.

Study design
This is an open-label, multi-center Phase 1/1b study with 574 planned participants. It has three groups: one receiving RMC-5127 alone, and two groups receiving RMC-5127 with either daraxonrasib or cetuximab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor participants for adverse events, vital signs, and ECG changes 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.

NCT07349537

Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Revolution Medicines, Inc.
~574 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:RMC-5127daraxonrasibcetuximab

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with adverse events (AEs)
Measured over Up to approximately 3 years
+4 more outcomes measured

Conditions

Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Pancreatic Adenocarcinoma
Pancreatic Ductal Adenocarcinoma (PDAC)
PDAC
CRC
NSCLC
Pancreatic Cancer
Lung Cancer (NSCLC)
Advanced Solid Tumors

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGTPase KRas

Where it's being run

9 sites across 7 states
Texas3
Connecticut1
Maryland1
Massachusetts1
Michigan1
New York1
Virginia1

Who to contact

Revolution Medicines Study Director
[email protected]
1-844-2-REVMED
Email the study team

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Eligibility criteria

Inclusion

At least 18 years old and has provided informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.
Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.
Measurable per RECIST v1.1
Adequate organ function (bone marrow, liver, kidney, coagulation).
Able to take oral medications.

Exclusion

Primary central nervous system (CNS) tumors
Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors).
Any conditions that may affect the ability to take or absorb study drug.
Major surgery within 28 days prior to receiving study drug(s).
Patient is unable or unwilling to comply with protocol-required study visits or procedures.

What this trial measures

  • Number of patients with adverse events (AEs)Up to approximately 3 years

    Number of patients with AEs as assessed by Common Terminology Criteria for Adverse Events CTCAE v5

  • Changes in vital signsUp to approximately 3 years

    Number of patients with changes from baseline in vital signs

  • Changes in electrocardiogram (ECG) test valuesUp to approximately 3 years

    Number of patients with changes from baseline in ECG test values

  • Changes in clinical laboratory test valuesUp to approximately 3 years

    Number of patients with changes from baseline in clinical laboratory test values

  • Dose Limiting ToxicitiesUp to 28 days

    Number of patients with dose limiting toxicities