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RMC-6291

Phase 1

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Revolution Medicines, Inc.|Last Updated: May 15, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment222
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05462717Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 222Sep 19, 2022Sep 30, 2027May 15, 202664 United States, Australia +11
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Study Endpoints
Primary Endpoints
Adverse events
up to 3 years

Number of participants with adverse events

Dose Limiting Toxicities
The first 21 days (i.e. Cycle 1)

Number of participants with dose limiting toxicities

Secondary Endpoints
Maximum Observed Blood Concentration of RMC-6291
7 Cycles
Time to Reach Maximum Blood Concentration of RMC-6291
7 Cycles
Area Under Blood Concentration Time Curve of RMC-6291
7 Cycles
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RMC-6291EXPERIMENTALDose Escalation and Dose Expansion
Interventions
NameTypeDescription
RMC-6291DRUGOral tablet once or twice a day
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * Subject must be ≥18 years of age. * Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor type...

Countries:United StatesAustraliaCzechiaFranceItalyMalaysiaPolandSerbiaSingaporeSouth KoreaSpainTaiwanThailand
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05462717primaryCompletionDate: changed
LOWMay 24, 2026NCT05462717studyFirstPostDate: changed