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

RecruitingPhase 1

A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors

Who can join

Ages 18 to 99 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Erasca, Inc. · Participants: 600 · Started: Jun 5, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06983743

Locations in the U.S.

CaliforniaProvidence Medical Group, Santa Rosa
ColoradoUniversity of Colorado, Aurora
FloridaFlorida Cancer Specalists, Sarasota
Moffitt Cancer Center, Tampa
MassachusettsMassachusetts General Hospital (MG), Boston
New YorkMemorial Sloan Kettering Cancer Center, New York
TexasThe University of Texas MD Anderson Cancer Center, Houston
University of Texas at Tyler, Tyler
VirginiaNEXT Virginia, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.