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ACTIVE NOT RECRUITING
NCT05222802
PHASE1

A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)

Sponsor: Katmai Pharmaceuticals Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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