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

Last updated: September 9, 2025
Sponsor: Erasca, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Neoplasm Metastasis

Treatment

ERAS-0015 in combination

ERAS-0015

Clinical Study ID

NCT06983743
ERAS-0015-01
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofstudy drug(s), for applicable cohorts.

  • There is no available standard systemic therapy available for the patient's tumorhistology 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

Exclusion Criteria:

  • Previous treatment with a RAS inhibitor

  • Is currently receiving another study therapy or has participated in a study of aninvestigational agent and received study therapy within 4 weeks of the first dose ofERAS-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 gastrointestinaldysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that mayaffect drug absorption

  • Have any underlying medical condition, psychiatric condition, or social situationthat, in the opinion of the Investigator, would compromise study administration asper protocol or compromise the assessment of AEs

  • Are pregnant or breastfeeding or expecting to conceive or father children within theprojected duration of the trial

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: ERAS-0015 in combination
Phase: 1
Study Start date:
June 05, 2025
Estimated Completion Date:
December 01, 2028

Study 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.

Connect with a study center

  • Florida Cancer Specalists

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Florida Cancer Specalists

    Sarasota 4172131, Florida 4155751 34232
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas at Tyler

    Tyler, Texas 75701
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • University of Texas at Tyler

    Tyler 4738214, Texas 4736286 75701
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • NEXT Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

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