* To evaluate the safety and tolerability of escalating doses of ERAS-801 in study participants with recurrent glioblastoma multiforme (GBM). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-801. * To evaluate the antitumor activity of ERAS-801. * To evaluate the PK profile of ERAS-801.
This is a Phase 1, open-label, multicenter clinical study evaluating ERAS-801 as a monotherapy. The study will initially commence with dose escalation of ERAS-801 in study participants with recurrent GBM. Once the MTD and/or RD has been determined from dose escalation, then dose expansion of ERAS-801 may commence in study participants with recurrent GBM harboring alterations in epidermal growth factor receptor (EGFR).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Administered orally
University of California, Los Angeles
Los Angeles, California, United States
Miami Cancer Institute-Baptist Heath South Florida
Miami, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System
Dose Limiting Toxicities (DLT)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Maximum Tolerated Dose (MTD)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Recommended Dose (RD)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Time frame: Assessed up to 24 months from time of first dose
Plasma concentration (Cmax)
Maximum plasma or serum concentration of ERAS-801
Time frame: Study Day 1 up to Day 29
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma or serum concentration of ERAS-801
Time frame: Study Day 1 up to Day 29
Area under the curve
Area under the plasma concentration-time curve of ERAS-801
Time frame: Study Day 1 up to Day 29
Half-life
Half-life of ERAS-801
Time frame: Study Day 1 up to Day 29
Objective Response Rate (ORR)
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Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Based on assessment of radiographic imaging per modified RANO response assessment
Time frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per modified RANO response assessment
Time frame: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Based on assessment of radiographic imaging per modified RANO response assessment
Time frame: Assessed up to 24 months from time of first dose