Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT07021898

Recruiting

BOREALIS-1: A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.

Interventional

Phase 1

The University of Texas MD Anderson Cancer Center

Sponsor: Erasca

Last Updated: December 3, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 will be given alone or in combination with other treatments.

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Treatment Category

Other Drugs

Required Mutations

None

Trial Started

August 6, 2025

Last Updated by Sponsor

December 3, 2025

Estimated Completion

August 1, 2028

Contact Study

Name:Erasca Clinical Team

Email:clinicaltrials@erasca.com

Phone:+1-858-465-6511

Name:Les Brail, Study Director, PhD

Eligibility

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 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 Criteria

* 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

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Design Details

AllocationNon-Randomized

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll200

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Escalating doses of ERAS-4001 administered orally.

Interventions:

ERAS-4001
ERAS-4001 in combination

Outcome Measures

Primary Outcome 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

Secondary Outcome Measures

Objective Response Rate (ORR)Assessed up to 24 months from time of first dose

Based on assessment of radiographic imaging per RECIST version 1.1

Duration of Response (DOR)Assessed up to 24 months from time of first dose

Based on assessment of radiographic imaging per RECIST version 1.1

Time to Response (TTR)Assessed up to 24 months from time of first dose

Based on assessment of radiographic imaging per RECIST version 1.1

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Trial Sites

This study has 5 trial sites

The University of Texas MD Anderson Cancer Center

Houston, Texas, US

Recruiting

Houston, Texas, 77030 US

The University of Texas MD Anderson Cancer Center

Recruiting

San Antonio, Texas, 78229 US

NEXT Oncology

Recruiting

Seattle, Washington, 98109 US

Fred Hutchinson Cancer Center

Recruiting

Irving, Texas, 75039 US

NEXT Oncology

Recruiting

Nashville, Tennessee, 32703 US

Sarah Cannon Research Institute (SCRI) Oncology Partners

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