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RMC-9805

Phase 1

Non-small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Revolution Medicines, Inc.|Last Updated: Jun 3, 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 Enrollment604
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06040541Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid TumorsPHASE1 RECRUITING 604Sep 7, 2023Apr 30, 2027Jun 3, 202617 United States
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Study Endpoints
Primary Endpoints
Adverse events
Up to 3 years

Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs

Dose Limiting Toxicities
21 days

Number of participants with Dose Limiting Toxicities (DLTs)

Secondary Endpoints
Maximum Observed Blood Concentration (Cmax) of RMC-9805 as monotherapy and in combination with RMC-6236, and Cmax of RMC-6236 in combination with RMC-9805
up to 21 weeks
Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805 as monotherapy and in combination with RMC-6236, and Tmax of RMC-6236 in combination with RMC-9805
up to 21 weeks
Area Under Blood Concentration Time Curve (AUC) of RMC-9805 as monotherapy and in combination with RMC-6236, and AUC of RMC-6236 in combination with RMC-9805
up to 21 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RMC-9805 monotherapy armEXPERIMENTALDose exploration and dose expansion
RMC-9805 plus RMC-6236 combination armEXPERIMENTALDose exploration and dose expansion
Interventions
NameTypeDescription
RMC-9805DRUGOral Tablets
RMC-6236DRUGOral Tablets
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation * Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage * ECOG performance status 0 or 1 * Adequate ...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMJun 3, 2026NCT06040541primaryCompletionDate: changed
MEDIUMJun 3, 2026NCT06040541primaryCompletionDate: changed
LOWMay 26, 2026NCT06040541primaryCompletionDate: changed
LOWMay 24, 2026NCT06040541studyFirstPostDate: changed