A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
Recruiting now · Phase 1
Conditions studied: Metastatic Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT07021898
- Run by
- Erasca, Inc.
- People needed
- 200
- Starts
- 2025-08-06
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-12-03
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville, Tennessee, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- NEXT Oncology — Irving, Texas, United States (enrolling)
- NEXT Oncology — San Antonio, Texas, United States (enrolling)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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