A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors
Summary
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.
Detailed description
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.
Arms & interventions
- DrugERAS-4001
ERAS-4001 Administered orally
- DrugERAS-4001 in combination
ERAS-4001 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-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
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)
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, 32703
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology
Irving, Texas, 75039
NEXT Oncology
San Antonio, Texas, 78229
Fred Hutchinson Cancer Center
Seattle, Washington, 98109