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

Study Purpose

  • - 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05222802
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Erasca, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Les Brail
Principal Investigator Affiliation Medical Director
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Additional Details

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).

Arms & Interventions

Arms

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.

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.

Interventions

Drug: - ERAS-801

Administered orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, Los Angeles, Los Angeles, California

Status

Address

University of California, Los Angeles

Los Angeles, California, 90095

Miami, Florida

Status

Address

Miami Cancer Institute-Baptist Heath South Florida

Miami, Florida, 33176

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Henry Ford Health System, Detroit, Michigan

Status

Address

Henry Ford Health System

Detroit, Michigan, 48202

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10022

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Nashville, Tennessee

Status

Address

Sarah Cannon Research Institute (Tennessee Oncology)

Nashville, Tennessee, 37203

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

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