A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors
Summary
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.
Detailed description
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.
Arms & interventions
- DrugERAS-0015
ERAS-0015 Administered orally
- DrugERAS-0015 in combination
ERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Outcome measures
Primary
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
Secondary
Objective Response Rate (ORR)
Time frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Time frame: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Time frame: Assessed up to 24 months from time of first dose
Eligibility criteria
Study locations (5)
Florida Cancer Specalists
Sarasota, Florida, 34232
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Texas at Tyler
Tyler, Texas, 75701
NEXT Virginia
Fairfax, Virginia, 22031