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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05222802
Recruitment Status : Active, not recruiting
First Posted : February 3, 2022
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Erasca, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: ERAS-801 Phase 1

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Actual Study Start Date : February 25, 2022
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation (Part 1)
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
Administered orally
Experimental: Dose Expansion (Part 2)
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
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLT) [ Time Frame: Study Day 1 up to Day 29 ]
    Based on adverse events observed during dose escalation

  2. Maximum Tolerated Dose (MTD) [ Time Frame: Study Day 1 up to Day 29 ]
    Based on adverse events observed during dose escalation

  3. Recommended Dose (RD) [ Time Frame: Study Day 1 up to Day 29 ]
    Based on adverse events observed during dose escalation

  4. Adverse Events [ Time Frame: Assessed up to 24 months from time of first dose ]
    Incidence and severity of treatment-emergent AEs and serious AEs


Secondary Outcome Measures :
  1. Plasma concentration (Cmax) [ Time Frame: Study Day 1 up to Day 29 ]
    Maximum plasma or serum concentration of ERAS-801

  2. Time to achieve Cmax (Tmax) [ Time Frame: Study Day 1 up to Day 29 ]
    Time to achieve maximum plasma or serum concentration of ERAS-801

  3. Area under the curve [ Time Frame: Study Day 1 up to Day 29 ]
    Area under the plasma concentration-time curve of ERAS-801

  4. Half-life [ Time Frame: Study Day 1 up to Day 29 ]
    Half-life of ERAS-801

  5. Objective Response Rate (ORR) [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on assessment of radiographic imaging per modified RANO response assessment

  6. Duration of Response (DOR) [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on assessment of radiographic imaging per modified RANO response assessment

  7. Time to Response (TTR) [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on assessment of radiographic imaging per modified RANO response assessment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05222802


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Florida
Miami Cancer Institute-Baptist Heath South Florida
Miami, Florida, United States, 33176
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, United States, 37203
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Erasca, Inc.
Investigators
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Study Director: Les Brail Medical Director
More Information
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Responsible Party: Erasca, Inc.
ClinicalTrials.gov Identifier: NCT05222802    
Other Study ID Numbers: ERAS-801-01
First Posted: February 3, 2022    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erasca, Inc.:
GBM
EGFR
epidermal growth factor receptor
alteration
ERBB1
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue