NCT05222802

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

A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Katmai Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	ERAS-801	Administered orally

Timeline

• Start date: 2022-02-25
• Primary completion: 2025-08-31
• Completion: 2025-09-30
• First posted: 2022-02-03
• Last updated: 2025-08-17

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study