Clinical trial · Interventional
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
NCT05222802CI-TRIAL-00093782active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS-801 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation (Part 1)
- 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.
- interventionNames
- Drug: ERAS-801
- type
- EXPERIMENTAL
- label
- Dose Expansion (Part 2)
- 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.
- interventionNames
- Drug: ERAS-801
Primary outcomes (4)
- measure
- Dose Limiting Toxicities (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.