A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Recruiting · NCT06983743 · Interventional (participants receive a specific treatment) · Lead sponsor: Erasca, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ERAS-0015ERAS-0015 in combination
What this trial is about
The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 will be given alone or in combination with other treatments.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.
- 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
Where it is running
24 locations listed across 6 US states.
- Providence Medical Group - Santa Rosa, California, United States
- Providence Medical Group - Santa Rosa, California, United States
- Providence Medical Group - Santa Rosa, California, United States
- Florida Cancer Specalists - Sarasota, Florida, United States
- Florida Cancer Specalists - Sarasota, Florida, United States
- Florida Cancer Specalists - Sarasota, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Massachusetts General Hospital (MG) - Boston, Massachusetts, United States
- Massachusetts General Hospital (MG) - Boston, Massachusetts, United States
- Massachusetts General Hospital (MG) - Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- University of Texas at Tyler - Tyler, Texas, United States
- University of Texas at Tyler - Tyler, Texas, United States
- University of Texas at Tyler - Tyler, Texas, United States
- NEXT Virginia - Fairfax, Virginia, United States
- NEXT Virginia - Fairfax, Virginia, United States
- NEXT Virginia - Fairfax, Virginia, United States