A Study of ERAS-0015 for Advanced or Metastatic Solid Tumors

This study is testing a new oral medicine called ERAS-0015 for people with advanced or metastatic (spread to other parts of the body) solid tumors that have certain genetic changes (RAS mutations). The main goal is to see if ERAS-0015 is safe and tolerable, both when given alone and when combined with other cancer treatments like KEYTRUDA® (pembrolizumab) or Vectibix (panitumumab). You may be able to join if you are 18 or older, have a solid tumor with specific mutations, and standard treatments are not available, not working, or you can't tolerate them. The study is currently trying to find the best dose of ERAS-0015.

Study design
This is an open-label (meaning you and your doctor will know what treatment you are receiving) Phase 1/1b study, which means it's an early-stage trial. It plans to enroll up to 600 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety measures, like dose-limiting toxicities and maximum tolerated dose, are measured from the first day of the study 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.

NCT06983743

A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18–99InterventionalTreatment
Erasca, Inc.
~600 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:ERAS-0015ERAS-0015 in combination

At a glance

Recruiting sites
8 of 8 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
Metastatic Solid Tumors
8 sites across 6 states
Florida2
Texas2
California1
Massachusetts1
New York1
Virginia1
  • Gerri Lee · STUDY_DIRECTOR · Erasca, Inc.

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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), for applicable cohorts.
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. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.
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-0015
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
  • 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 65

    Maximum plasma concentration of ERAS-0015

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

    Time to achieve maximum plasma concentration of ERAS-0015

  • Area under the curveStudy Day 1 up to 65

    Area under the plasma concentration-time curve of ERAS-0015

  • Half-lifeStudy Day 1 up to 65

    Half-life of ERAS-0015