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.
This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 in combination with other cancer therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
ERAS-0015 Administered orally
ERAS-0015 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Florida Cancer Specalists
Sarasota, Florida, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Dose Limiting Toxicities (DLT)
Based on toxicities observed
Time frame: Study Day 1 up to Day 21
Maximum tolerated dose (MTD)
Based on toxicities observed
Time frame: Study Day 1 up to Day 21
Recommended dose for expansion (RDE)
Based on toxicities observed
Time frame: Study Day 1 up to Day 21
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Time frame: Study Day 1 up to Day 21
Plasma concentration (Cmax)
Maximum plasma concentration of ERAS-0015
Time frame: Study Day 1 up to 65
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma concentration of ERAS-0015
Time frame: Study Day 1 up to 65
Area under the curve
Area under the plasma concentration-time curve of ERAS-0015
Time frame: Study Day 1 up to 65
Half-life
Half-life of ERAS-0015
Time frame: Study Day 1 up to 65
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Les Brail, Study Director, PhD
CONTACT
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University of Texas at Tyler
Tyler, Texas, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGTime frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose