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A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT07021898.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Approved
Name Not Available
This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-4001
as a monotherapy and in combination with other cancer therapies. The study will commence
with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of
ERAS-4001 in combination with other cancer therapies.