Glioblastoma MultiformePhase 1NCT05222802
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
A Phase 1 study testing ERAS-801 in people with Glioblastoma Multiforme, run by Katmai Pharmaceuticals Inc. at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- ERAS-801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 8 sitesUnited States
- Study dates
- 25 Feb 2022to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
University of California, Los Angeles
Los Angeles, California, 90095
Miami Cancer Institute-Baptist Heath South Florida
Miami, Florida, 33176
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
- 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.
Read the 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).
- Conditions
- Glioblastoma Multiforme
- Being tested
- ERAS-801
- Keywords
- GBM, EGFR, epidermal growth factor receptor, alteration, ERBB1
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS-801Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ERAS-801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
Based on adverse events observed during dose escalation
Measured: Study Day 1 up to Day 29
Maximum Tolerated Dose (MTD)
Based on adverse events observed during dose escalation
Measured: Study Day 1 up to Day 29
Recommended Dose (RD)
Based on adverse events observed during dose escalation
Measured: Study Day 1 up to Day 29
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Measured: Assessed up to 24 months from time of first dose
Secondary outcomes (7)
Plasma concentration (Cmax)
Maximum plasma or serum concentration of ERAS-801
Measured: Study Day 1 up to Day 29
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma or serum concentration of ERAS-801
Measured: Study Day 1 up to Day 29
Area under the curve
Area under the plasma concentration-time curve of ERAS-801
Measured: Study Day 1 up to Day 29
Half-life
Half-life of ERAS-801
Measured: Study Day 1 up to Day 29
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per modified RANO response assessment
Measured: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per modified RANO response assessment
Measured: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Based on assessment of radiographic imaging per modified RANO response assessment
Measured: Assessed up to 24 months from time of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start25 Feb 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katmai Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Erasca, Inc.
- Responsible party
- Sponsor
- Investigators
- Les Brail, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222802
- Sponsor's protocol ID
- ERAS-801-01
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2022
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
- ClinicalTrials.gov ID
- NCT05222802
- Acronym / sponsor ID
- ERAS-801-01
- Conditions
- Glioblastoma Multiforme
- Keywords
- GBM, EGFR, epidermal growth factor receptor, alteration, ERBB1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Katmai Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Erasca, Inc.
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Part 1) | Experimental | Drug: ERAS-801ERAS-801 will be orally administered to study participants with recurrent GBM in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Expansion (Part 2) | Experimental | Drug: ERAS-801ERAS-801 will be orally administered at the recommended dose (as determined from Part 1) to study participants with recurrent GBM harboring alterations in EGFR. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS-801Administered orally | Drug | Dose Escalation (Part 1), Dose Expansion (Part 2) |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: Study Day 1 up to Day 29
Based on adverse events observed during dose escalation
Maximum Tolerated Dose (MTD)
Time frame: Study Day 1 up to Day 29
Based on adverse events observed during dose escalation
Recommended Dose (RD)
Time frame: Study Day 1 up to Day 29
Based on adverse events observed during dose escalation
Adverse Events
Time frame: Assessed up to 24 months from time of first dose
Incidence and severity of treatment-emergent AEs and serious AEs
7 secondary outcomes
Plasma concentration (Cmax)
Time frame: Study Day 1 up to Day 29
Time to achieve Cmax (Tmax)
Time frame: Study Day 1 up to Day 29
Area under the curve
Time frame: Study Day 1 up to Day 29
Half-life
Time frame: Study Day 1 up to Day 29
Objective Response Rate (ORR)
Time frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Time frame: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Time frame: Assessed up to 24 months from time of first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Les Brail study director
Medical Director
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ERAS-801 in people with Glioblastoma Multiforme, run by Katmai Pharmaceuticals Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) (time frame: Study Day 1 up to Day 29). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.