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RMC-5552

Phase 1

Solid Tumors | Small molecule | Oncology |Revolution Medicines, Inc.|Last Updated: Apr 15, 2025

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 Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04774952Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid TumorsPHASE1 COMPLETED 58Apr 7, 2021Jun 28, 2024Apr 15, 20258 United States
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
up to 3 years

Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values or vital signs for RMC-5552 monotherapy

Number of participants with dose limiting toxicities (DLTs)
21 days

Incidence and nature of DLTs with RMC-5552 monotherapy

Secondary Endpoints
Cmax
up to 3 years
Tmax
up to 3 years
Area Under the Curve (AUC)
up to 3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RMC-5552EXPERIMENTALRMC-5552 for IV administration
Interventions
NameTypeDescription
RMC-5552DRUGRMC-5552 for IV administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Participants (male or female) ≥18 years of age * Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type * Easter...

Countries:United States
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