Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ERAS-801 · 1 trial · 1 indication
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...
ERAS-801 is an investigational small molecule being studied for the treatment of Glioblastoma Multiforme (GBM), a type of brain cancer. It is currently in Phase 1 clinical development and has not yet been approved by the FDA. The drug is being evaluated in patients with recurrent GBM.
ERAS-801 targets EGFR, a protein that can drive tumor growth when mutated or overexpressed. By inhibiting EGFR, the drug aims to block signals that promote cancer cell proliferation. This mechanism is being explored in the context of Glioblastoma Multiforme, where EGFR alterations are common.
ERAS-801 is being developed by Erasca, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ERAS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with recurrent Glioblastoma Multiforme.
ERAS-801 is in Phase 1 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being tested in clinical trials. The drug has been granted Fast Track and Orphan Drug designations by the FDA for its potential use in Glioblastoma Multiforme.
ERAS-801 is being studied in a Phase 1 clinical trial with the identifier NCT05222802, titled 'A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)'. This trial is active but not recruiting, with an enrollment of 52 participants in the United States.
No, ERAS-801 is the drug being studied, while THUNDERBBOLT-1 is the name of the clinical trial evaluating it. The trial, identified as NCT05222802, is a Phase 1 study in patients with recurrent Glioblastoma Multiforme. The drug itself is a small molecule targeting EGFR.