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

Launched by ERASCA, INC. · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called ERAS-4001 in patients who have advanced or metastatic solid tumors, specifically those with certain mutations in a gene called KRAS. The main goal is to find out if ERAS-4001 is safe to use and how well it can be tolerated by patients. Participants may receive this drug on its own or along with other treatments. The trial is currently not recruiting participants, but it aims to include adults aged 18 and older who meet specific criteria, such as having a documented tumor type and mutation, and having no effective standard treatment options available for their condition.

To be eligible for the trial, participants should be able to swallow pills and have good overall health, as measured by a standard performance scale. They should also be willing to follow the study's requirements and attend necessary appointments. However, some individuals may not be able to join the study if they have received similar treatments in the past, have certain health conditions, or are pregnant or breastfeeding. If you or a loved one are considering participation, it's important to discuss any questions or concerns with your healthcare provider to understand what to expect during the trial.

Gender

ALL

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