Back to resultsA Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Primary Purpose
Glioblastoma Multiforme
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ERAS-801
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring GBM, EGFR, epidermal growth factor receptor, alteration, ERBB1
Eligibility Criteria
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
Sites / Locations
- University of California, Los AngelesRecruiting
- Miami Cancer Institute-Baptist Heath South FloridaRecruiting
- Dana Farber Cancer InstituteRecruiting
- Henry Ford Health SystemRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Cleveland Clinic FoundationRecruiting
- Sarah Cannon Research Institute (Tennessee Oncology)Recruiting
- Huntsman Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Escalation (Part 1)
Dose Expansion (Part 2)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Dose Limiting Toxicities (DLT)
Based on adverse events observed during dose escalation
Maximum Tolerated Dose (MTD)
Based on adverse events observed during dose escalation
Recommended Dose (RD)
Based on adverse events observed during dose escalation
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Secondary Outcome Measures
Plasma concentration (Cmax)
Maximum plasma or serum concentration of ERAS-801
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma or serum concentration of ERAS-801
Area under the curve
Area under the plasma concentration-time curve of ERAS-801
Half-life
Half-life of ERAS-801
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per modified RANO response assessment
Duration of Response (DOR)
Based on assessment of radiographic imaging per modified RANO response assessment
Time to Response (TTR)
Based on assessment of radiographic imaging per modified RANO response assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05222802
Brief Title
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Official Title
A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasca, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
GBM, EGFR, epidermal growth factor receptor, alteration, ERBB1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation (Part 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Expansion (Part 2)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ERAS-801
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities (DLT)
Description
Based on adverse events observed during dose escalation
Time Frame
Study Day 1 up to Day 29
Title
Maximum Tolerated Dose (MTD)
Description
Based on adverse events observed during dose escalation
Time Frame
Study Day 1 up to Day 29
Title
Recommended Dose (RD)
Description
Based on adverse events observed during dose escalation
Time Frame
Study Day 1 up to Day 29
Title
Adverse Events
Description
Incidence and severity of treatment-emergent AEs and serious AEs
Time Frame
Assessed up to 24 months from time of first dose
Secondary Outcome Measure Information:
Title
Plasma concentration (Cmax)
Description
Maximum plasma or serum concentration of ERAS-801
Time Frame
Study Day 1 up to Day 29
Title
Time to achieve Cmax (Tmax)
Description
Time to achieve maximum plasma or serum concentration of ERAS-801
Time Frame
Study Day 1 up to Day 29
Title
Area under the curve
Description
Area under the plasma concentration-time curve of ERAS-801
Time Frame
Study Day 1 up to Day 29
Title
Half-life
Description
Half-life of ERAS-801
Time Frame
Study Day 1 up to Day 29
Title
Objective Response Rate (ORR)
Description
Based on assessment of radiographic imaging per modified RANO response assessment
Time Frame
Assessed up to 24 months from time of first dose
Title
Duration of Response (DOR)
Description
Based on assessment of radiographic imaging per modified RANO response assessment
Time Frame
Assessed up to 24 months from time of first dose
Title
Time to Response (TTR)
Description
Based on assessment of radiographic imaging per modified RANO response assessment
Time Frame
Assessed up to 24 months from time of first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erasca Clinical Team
Phone
+1-858-465-6511
Email
clinicaltrials@erasca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Les Brail
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Cancer Institute-Baptist Heath South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute (Tennessee Oncology)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
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