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RMC-5127

Phase 1

Non-small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Revolution Medicines, Inc.|Last Updated: Jul 10, 2026

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

CONTROLLEDDMC
Total Trials1
Total Enrollment574

FDA Designations

No designations recorded

Clinical trial landscape

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)

LOWJul 10, 2026NCT07349537lastUpdatePostDate: changed
LOWJul 10, 2026NCT07349537lastUpdatePostDate: changed

Frequently asked questions about RMC-5127

What is RMC-5127 used for in NSCLC?

RMC-5127 is an investigational small molecule being studied for the treatment of non-small cell lung cancer (NSCLC). It is in Phase 1 clinical development for patients with advanced KRAS G12V-mutant solid tumors, including NSCLC, colorectal cancer, and pancreatic adenocarcinoma.

What does RMC-5127 target?

RMC-5127 targets RAS(ON) G12V, a specific mutant form of the RAS protein. By targeting this oncogenic variant, the drug aims to interfere with cancer cell signaling driven by the G12V mutation.

Who makes RMC-5127?

RMC-5127 is being developed by Revolution Medicines, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVMD. The company is conducting clinical trials for this investigational oncology drug.

What phase is RMC-5127 in?

RMC-5127 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients with advanced KRAS G12V-mutant solid tumors.

What clinical trials is RMC-5127 in?

RMC-5127 is being evaluated in a single Phase 1 clinical trial registered as NCT07349537, titled 'Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors.' The trial is recruiting in the United States and plans to enroll 574 participants aged 18 years and older.