Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05222802 | A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1) | PHASE1 | ACTIVE NOT_RECRUITING | 52 | — | — | Feb 25, 2022 | Sep 30, 2025 | Aug 17, 2025 | 8 | United States |
Based on adverse events observed during dose escalation
Based on adverse events observed during dose escalation
Based on adverse events observed during dose escalation
Incidence and severity of treatment-emergent AEs and serious AEs
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| ERAS-801 | DRUG | Administered orally |
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 medica...