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ERAS-4001

Phase 1

Metastatic Solid Tumors | Small molecule | Oncology |Erasca, Inc.|Last Updated: Dec 3, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07021898A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.PHASE1 RECRUITING 200 — — Aug 6, 2025Dec 1, 2028Dec 3, 20255 United States
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicities (DLT)
Study Day 1 up to Day 21

Based on toxicities observed

Maximum tolerated dose (MTD)
Study Day 1 up to Day 21

Based on toxicities observed

Recommended dose for expansion (RDE)
Study Day 1 up to Day 21

Based on toxicities observed

Adverse Events
Study Day 1 up to Day 21

Incidence and severity of treatment-emergent AEs and serious AEs

Plasma concentration (Cmax)
Study Day 1 up to Day 65

Maximum plasma concentration of ERAS-4001

Time to achieve Cmax (Tmax)
Study Day 1 up to Day 65

Time of achieve maximum plasma concentration of ERAS-4001

Area under the curve
Study Day 1 up to Day 65

Area under the plasma concentration-time curve of ERAS-4001

Half-life
Study Day 1 up to Day 65

Half-life of ERAS-4001

Secondary Endpoints
Objective Response Rate (ORR)
Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Assessed up to 24 months from time of first dose
Time to Response (TTR)
Assessed up to 24 months from time of first dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ERAS-4001 Monotherapy Dose Optimization.EXPERIMENTALEscalating doses of ERAS-4001 administered orally.
ERAS-4001 Combination Dose OptimizationEXPERIMENTALERAS-4001 administered orally with another investigational agent.
Interventions
NameTypeDescription
ERAS-4001DRUGERAS-4001 Administered orally
ERAS-4001 in combinationDRUGERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Age ≥ 18 years * Willing and able to give written informed consent * Pathological documentation of tumor type and mutation prior to the first dose of study drug(s) * There is no available standard systemic therapy available for the patient's tumor histology and/or molecular bi...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07021898primaryCompletionDate: changed
LOWMay 24, 2026NCT07021898studyFirstPostDate: changed