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A Study of ERAS-4001 for Advanced or Metastatic Solid Tumors with KRAS Mutations

This study is testing a new drug called ERAS-4001 in people with advanced or metastatic (spread to other parts of the body) solid tumors that have certain KRAS mutations. The main goal is to see if ERAS-4001 is safe and how much can be given without causing too many side effects. ERAS-4001 will be given by itself or in combination with other approved cancer treatments like Keytruda (pembrolizumab) or Vectibix (panitumumab). You may be able to join if you are at least 18 years old, have a solid tumor with a KRAS mutation, and have limited or no other standard treatment options. The study is looking to enroll about 200 participants, but its current status is unclear.

Study design
This is a Phase 1/1b, open-label study, meaning you and your doctors will know which treatment you are receiving. It will enroll about 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoints are measured from Study Day 1 up to Day 21.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07021898

A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.

Recruiting
PHASE1Ages 18–99InterventionalTreatment
Erasca, Inc.
~200 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:ERAS-4001ERAS-4001 in combination

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limiting Toxicities (DLT)
Measured over Study Day 1 up to Day 21
+7 more outcomes measured

Conditions

Metastatic Solid Tumors

Explore related trials

Solid NeoplasmGTPase KRas

Where it's being run

5 sites across 3 states
Texas3
Tennessee1
Washington1

Study leadership

  • Gerri Lee · STUDY_DIRECTOR · Erasca, Inc.

Who to contact

Erasca Clinical Team
[email protected]
+1-858-465-6511
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy
Able to swallow oral medication
Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Adequate cardiovascular, hematological, liver, and renal function
Willing to comply with all protocol-required visits, assessments, and procedures

Exclusion

Previous treatment with a RAS inhibitor
Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-4001
Received prior palliative radiation within 14 days of Cycle 1, Day 1
Have primary central nervous system (CNS) tumors
Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption
Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs
Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

What this trial measures

  • 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 EventsStudy 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 curveStudy Day 1 up to Day 65

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

  • Half-lifeStudy Day 1 up to Day 65

    Half-life of ERAS-4001