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NCT06983743PHASE1Recruiting

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

Erasca, Inc.

Start Date

6/5/2025

Completion Date

12/1/2028

Summary

The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 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-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 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), 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 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-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

Interventions

DRUG

ERAS-0015

DRUG

ERAS-0015 in combination

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Conditions

Metastatic Solid Tumors

Locations

Providence Medical Group

Santa Rosa, California 95403

United States

Florida Cancer Specalists

Sarasota, Florida 34232

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Massachusetts General Hospital (MG)

Boston, Massachusetts 02114

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

University of Texas at Tyler

Tyler, Texas 75701

United States

NEXT Virginia

Fairfax, Virginia 22031

United States