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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05222802
• Other study ID #: ERAS-801-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 25, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: Erasca, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: September 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• ERAS-801
Administered orally

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Erasca, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities (DLT)	Based on adverse events observed during dose escalation	Study Day 1 up to Day 29
Primary	Maximum Tolerated Dose (MTD)	Based on adverse events observed during dose escalation	Study Day 1 up to Day 29
Primary	Recommended Dose (RD)	Based on adverse events observed during dose escalation	Study Day 1 up to Day 29
Primary	Adverse Events	Incidence and severity of treatment-emergent AEs and serious AEs	Assessed up to 24 months from time of first dose
Secondary	Plasma concentration (Cmax)	Maximum plasma or serum concentration of ERAS-801	Study Day 1 up to Day 29
Secondary	Time to achieve Cmax (Tmax)	Time to achieve maximum plasma or serum concentration of ERAS-801	Study Day 1 up to Day 29
Secondary	Area under the curve	Area under the plasma concentration-time curve of ERAS-801	Study Day 1 up to Day 29
Secondary	Half-life	Half-life of ERAS-801	Study Day 1 up to Day 29
Secondary	Objective Response Rate (ORR)	Based on assessment of radiographic imaging per modified RANO response assessment	Assessed up to 24 months from time of first dose
Secondary	Duration of Response (DOR)	Based on assessment of radiographic imaging per modified RANO response assessment	Assessed up to 24 months from time of first dose
Secondary	Time to Response (TTR)	Based on assessment of radiographic imaging per modified RANO response assessment	Assessed up to 24 months from time of first dose