ERAS-4001 for advanced or metastatic solid tumors with KRAS mutations.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1/1b, open-label, multicenter dose-finding study of ERAS-4001 given as monotherapy and in combination with other cancer treatments. The study begins with dose optimization of ERAS-4001 alone and then proceeds to dose-finding for ERAS-4001 combined with other therapies. Eligible patients are adults with advanced or metastatic solid tumors harboring specified KRAS mutations and adequate organ function and performance status. Primary objectives focus on safety, tolerability, and identifying recommended doses, with exploratory measures of antitumor activity.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Erasca Clinical Team
• Email: clinicaltrials@erasca.com
• Phone: +1-858-465-6511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.