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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
ERAS-4001 Administered orally
ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Oncology
Irving, 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-4001
Time frame: Study Day 1 up to Day 65
Time to achieve Cmax (Tmax)
Time of achieve maximum plasma concentration of ERAS-4001
Time frame: Study Day 1 up to Day 65
Area under the curve
Area under the plasma concentration-time curve of ERAS-4001
Time frame: Study Day 1 up to Day 65
Half-life
Half-life of ERAS-4001
Time frame: Study Day 1 up to Day 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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NEXT Oncology
San Antonio, Texas, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, 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