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

NCT05222802 · tracked via the Priya Life Science USA tracker

Sponsor

Katmai Pharmaceuticals Inc.

Phase

Phase 1

Started

2022-02-25

Last updated

2025-08-17

Condition(s) studied

Glioblastoma Multiforme

Investigational drug(s) / intervention(s)

ERAS-801

ERAS-801: Administered orally

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years * Willing and able to give written informed consent * Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria * Adequate organ function * Willing to comply with all protocol-required visits, assessments, and procedures * Able to swallow oral medication Exclusion Criteria: * Prior treatment with an EGFR inhibitor for Glioblastoma * Currently enrolled in another therapeutic study * History of clinically significant cardiovascular disease * Gastrointestinal conditions that may affect administration/absorption of oral medications * Have an active infection (bacterial, fungal, or viral) requiring systemic therapy * Pregnant or breastfeeding women * Any serious underlying medical or psychiatric condition or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study * Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients

Primary outcome measure(s)

Dose Limiting Toxicities (DLT) — Study Day 1 up to Day 29
Based on adverse events observed during dose escalation
Maximum Tolerated Dose (MTD) — Study Day 1 up to Day 29
Based on adverse events observed during dose escalation
Recommended Dose (RD) — Study Day 1 up to Day 29
Based on adverse events observed during dose escalation
Adverse Events — Assessed up to 24 months from time of first dose
Incidence and severity of treatment-emergent AEs and serious AEs

Trial sites (8)

Facility	City	Region
University of California, Los Angeles	Los Angeles	California
Miami Cancer Institute-Baptist Heath South Florida	Miami	Florida
Dana Farber Cancer Institute	Boston	Massachusetts
Henry Ford Health System	Detroit	Michigan
Memorial Sloan Kettering Cancer Center	New York	New York
Cleveland Clinic Foundation	Cleveland	Ohio
Sarah Cannon Research Institute (Tennessee Oncology)	Nashville	Tennessee
Huntsman Cancer Institute	Salt Lake City	Utah

Other trials for the same condition

A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB) Active, not recruiting

NG101m Adjuvant Therapy in Glioblastoma Patients Starting soon

A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM Active, not recruiting

Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab Recruiting

Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05222802 on ClinicalTrials.gov ↗ ← All trials in the USA