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ERAS-4001

Phase 1

Metastatic Solid Tumors | Small molecule | Oncology |Erasca, Inc.|Last Updated: Dec 3, 2025

Target and mechanism

Molecular targetKRAS
Target classGene
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

ERAS-4001 · 1 trial · 1 indication

Phase 1 1
NCT07021898A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.Metastatic Solid Tumors
RECRUITING200 Analytics
PHASE1RECRUITING
A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
Metastatic Solid TumorsUnlock trial analytics

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 to 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 (matched to "Metastatic Solid Tumors")

Frequently asked questions about ERAS-4001

What is ERAS-4001 used for?

ERAS-4001 is an investigational small molecule being developed for the treatment of metastatic solid tumors. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in patients with advanced or metastatic solid tumors.

What does ERAS-4001 target?

ERAS-4001 targets KRAS, a gene that encodes a protein involved in cell signaling and growth. By targeting KRAS, the drug aims to interfere with pathways that drive tumor growth. This mechanism is being evaluated in the context of metastatic solid tumors.

Who is developing ERAS-4001?

ERAS-4001 is being developed by Erasca, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ERAS. Erasca is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is ERAS-4001 in?

ERAS-4001 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial is currently recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in patients with metastatic solid tumors.

What clinical trials is ERAS-4001 in?

ERAS-4001 is being studied in a Phase 1 clinical trial with the identifier NCT07021898. This trial is titled 'A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors' and is currently recruiting participants in the United States. The trial aims to enroll approximately 200 patients aged 18 years and older.

Is ERAS-4001 the same as other KRAS inhibitors?

ERAS-4001 is a distinct investigational drug developed by Erasca, Inc. While it targets KRAS, it is not the same as other KRAS inhibitors. The drug is currently in Phase 1 trials for metastatic solid tumors, and its specific properties and efficacy are being evaluated separately from other agents in this class.