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RMC-5127

Phase 1

Non-small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Revolution Medicines, Inc.|Last Updated: Jun 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment574
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07349537Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid TumorsPHASE1 RECRUITING 574Jan 8, 2026Oct 1, 2028Jun 1, 20265 United States
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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 — N/A
SexALL
Healthy VolunteersNo
Study Sites5

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)
LOWJun 2, 2026NCT07349537lastUpdatePostDate: changed
LOWJun 2, 2026NCT07349537lastUpdatePostDate: changed
LOWJun 2, 2026NCT07349537lastUpdatePostDate: changed
LOWMay 26, 2026NCT07349537primaryCompletionDate: changed
LOWMay 24, 2026NCT07349537studyFirstPostDate: changed