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NCT07021898PHASE1Recruiting

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

Erasca, Inc.

Start Date

8/6/2025

Completion Date

12/1/2028

Summary

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.

Detailed Description

This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-4001 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of ERAS-4001 in combination with other cancer therapies.

Eligibility Criteria

Age Range: 18 years to 99 years

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

Interventions

DRUG

ERAS-4001

DRUG

ERAS-4001 in combination

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Conditions

Metastatic Solid Tumors

Locations

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee 32703

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Oncology

Irving, Texas 75039

United States

NEXT Oncology

San Antonio, Texas 78229

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States