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

Launched by ERASCA, INC. · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called ERAS-0015 to see if it is safe and tolerable for patients with advanced or metastatic solid tumors that have specific RAS mutations. The trial aims to find out how well this drug works on its own or when used with other treatments. If you are an adult aged 18 or older, have a documented tumor type and mutation, and have not found effective standard therapy for your condition, you may be eligible to participate.

Participants in this study will receive ERAS-0015 and will need to attend scheduled visits for assessments and procedures to monitor their health. It’s important to note that if you have had previous treatments with RAS inhibitors, are currently involved in another clinical study, or have certain medical conditions, you may not qualify for this trial. As the study is not yet recruiting, more information will be available once it begins.

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), 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
• • 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