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Clinical Trials in the USA / NCT05222802
Active, not recruiting Phase 1

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
No
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)

FacilityCityRegionStatus
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 Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM Recruiting
Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab Active, not recruiting
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma Active, not recruiting
A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM Active, not recruiting
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma Active, not 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