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RMC-5127

Phase 1

Non-small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Revolution Medicines, Inc.|Trials Updated: Sep 17, 2026

RMC-5127 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2026

RMC-5127 target and mechanism

Molecular targetRAS(ON) G12V
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment574

FDA Designations

No designations recorded

RMC-5127 clinical trials

RMC-5127 · 1 trial · 10 indications

Phase 1 1
NCT07349537Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid TumorsNon-small Cell Lung Cancer (NSCLC)
RECRUITING574 Analytics
PHASE1RECRUITING
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Non-small Cell Lung Cancer (NSCLC)Unlock trial analytics

Study Endpoints

Primary Endpoints

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 signs
Up to approximately 3 years

Number of patients with changes from baseline in vital signs

Changes in electrocardiogram (ECG) test values
Up to approximately 3 years

Number of patients with changes from baseline in ECG test values

Changes in clinical laboratory test values
Up to approximately 3 years

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

Dose Limiting Toxicities
Up to 28 days

Number of patients with dose limiting toxicities

Secondary Endpoints

Cmax concentrations of RMC-5127 and daraxonrasib
Up to Cycle 5 Day 1 (each cycle is up to 28 days)
Tmax concentration of RMC-5127 and daraxonrasib
Up to Cycle 5 Day 1 (each cycle is up to 28 days)
AUC concentrations of RMC-5127 and daraxonrasib
Up to Cycle 5 Day 1 (each cycle is up to 28 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: RMC-5127 MonotherapyEXPERIMENTALDose Escalation and Dose Expansion
Arm B: RMC-5127 + Daraxonrasib CombinationEXPERIMENTALDose Escalation and Dose Expansion
Arm C: RMC-5127 + Cetuximab CombinationEXPERIMENTALDose Escalation and Dose Expansion

Interventions

NameTypeDescription
RMC-5127DRUGoral tablets
daraxonrasibDRUGoral tablets
cetuximabDRUGIV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * 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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 17, 2026NCT07349537lastUpdatePostDate: changed
LOWSep 17, 2026NCT07349537lastUpdatePostDate: changed

Frequently asked questions about RMC-5127

What is RMC-5127?

RMC-5127 is an investigational small molecule developed by Revolution Medicines, Inc. for the treatment of advanced solid tumors, including non-small cell lung cancer (NSCLC). It is a RAS(ON) G12V inhibitor currently in Phase 1 clinical development and is not yet approved for any indication.

What is RMC-5127 used for in NSCLC?

RMC-5127 is being studied for use in non-small cell lung cancer (NSCLC) and other advanced solid tumors that carry a KRAS G12V mutation. It is an investigational therapy in Phase 1 testing and has not been approved for the treatment of NSCLC or any other cancer.

What does RMC-5127 target?

RMC-5127 targets RAS(ON) G12V, the active, GTP-bound form of the KRAS G12V mutant protein. By binding this RAS(ON) state, the small molecule is designed to inhibit signaling driven by the G12V mutation. The trial enrolls patients whose tumors are biomarker-selected for KRAS G12V.

Who makes RMC-5127?

RMC-5127 is developed by Revolution Medicines, Inc., a clinical-stage oncology company that trades on the Nasdaq under the ticker RVMD. Revolution Medicines is running the Phase 1 study of RMC-5127 in the United States.

What phase is RMC-5127 in?

RMC-5127 is in Phase 1 clinical development. It has one active, recruiting Phase 1 trial and no completed trials. RMC-5127 is investigational and has not received FDA approval for any indication.

What clinical trials is RMC-5127 in?

RMC-5127 is being evaluated in the Phase 1 trial NCT07349537, titled Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors. The trial is recruiting in the United States, has an estimated enrollment of 574 participants, and enrolls adults 18 years and older with advanced solid tumors.