Actively Recruiting
A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
Led by Erasca, Inc. · Updated on 2025-12-03
200
Participants Needed
5
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 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)
- No available standard systemic therapy for the patient's tumor or standard therapy is intolerable, ineffective, inaccessible, or refused
- Able to swallow oral medication
- 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 will not qualify if you...
- Previous treatment with a RAS inhibitor
- Currently receiving another study therapy or participated in an investigational study within 4 weeks before first ERAS-4001 dose
- Received prior palliative radiation within 14 days before Cycle 1, Day 1
- Have primary central nervous system tumors
- Prior surgery or gastrointestinal dysfunction affecting drug absorption
- Any medical, psychiatric, or social condition that may compromise study participation or assessment of adverse events
- Pregnant, breastfeeding, or expecting to conceive or father children during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States, 32703
Actively Recruiting
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
NEXT Oncology
Irving, Texas, United States, 75039
Actively Recruiting
4
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
5
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
E
Erasca Clinical Team
CONTACT
L
Les Brail, Study Director, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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