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A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Sponsor: Katmai Pharmaceuticals Inc.
Summary
* 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.
Official title: A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2022-02-25
Completion Date
2025-09-30
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
ERAS-801
Administered orally
Locations (8)
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
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