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

NCT05222802 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ERAS-801-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Glioblastoma Multiforme

Keywords

GBM; EGFR; epidermal growth factor receptor; alteration; ERBB1

Outcome Measures

Primary Outcomes (4)

• Dose Limiting Toxicities (DLT)

  Based on adverse events observed during dose escalation

  Study Day 1 up to Day 29

• Maximum Tolerated Dose (MTD)

  Based on adverse events observed during dose escalation

  Study Day 1 up to Day 29

• Recommended Dose (RD)

  Based on adverse events observed during dose escalation

  Study Day 1 up to Day 29

• Adverse Events

  Incidence and severity of treatment-emergent AEs and serious AEs

  Assessed up to 24 months from time of first dose

Secondary Outcomes (7)

• Plasma concentration (Cmax)

  Study Day 1 up to Day 29

• Time to achieve Cmax (Tmax)

  Study Day 1 up to Day 29

• Area under the curve

  Study Day 1 up to Day 29

• Half-life

  Study Day 1 up to Day 29

• Objective Response Rate (ORR)

  Assessed up to 24 months from time of first dose

Study Arms (2)

Dose Escalation (Part 1)

EXPERIMENTAL

ERAS-801 will be orally administered to study participants with recurrent GBM in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.

Drug: ERAS-801

Dose Expansion (Part 2)

EXPERIMENTAL

ERAS-801 will be orally administered at the recommended dose (as determined from Part 1) to study participants with recurrent GBM harboring alterations in EGFR.

Drug: ERAS-801

Interventions

ERAS-801 DRUG

Administered orally

Dose Escalation (Part 1); Dose Expansion (Part 2)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Katmai Pharmaceuticals Inc.: lead
• Erasca, Inc.: collaborator

Study Sites (8)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Miami Cancer Institute-Baptist Heath South Florida

Miami, Florida, 33176, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Sarah Cannon Research Institute (Tennessee Oncology)

Nashville, Tennessee, 37203, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Les Brail

  Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: February 25, 2022
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)