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Clinical Trials in the USA / NCT07021898
Recruiting Phase 1

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

NCT07021898 · tracked via the Priya Life Science USA tracker
Sponsor
Erasca, Inc.
Phase
Phase 1
Started
2025-08-06
Last updated
2025-12-03

Condition(s) studied

Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

ERAS-4001ERAS-4001 in combination

ERAS-4001: ERAS-4001 Administered orally

ERAS-4001 in combination: ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Sarah Cannon Research Institute (SCRI) Oncology Partners Nashville Tennessee Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
NEXT Oncology Irving Texas Recruiting
NEXT Oncology San Antonio Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting

More Erasca, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07021898 on ClinicalTrials.gov ↗ ← All trials in the USA