🔎 Trials Near Me

Home › Metastatic Cancer › NCT07021898

A Study of ERAS-4001 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-4001 Monotherapy and in Combination in Patients With 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)
* 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

About the study

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.

What is being tested

Sponsor: Erasca, Inc. · Participants: 200 · Started: Aug 6, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07021898

Locations in the U.S.

TennesseeSarah Cannon Research Institute (SCRI) Oncology Partners, Nashville
TexasThe University of Texas MD Anderson Cancer Center, Houston
NEXT Oncology, Irving
NEXT Oncology, San Antonio
WashingtonFred Hutchinson Cancer Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.