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 drug being developed by Erasca, Inc. for the treatment of glioblastoma multiforme, an aggressive form of brain cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. It is designed to target EGFR.
ERAS-801 is being studied for use in recurrent glioblastoma multiforme, a type of brain cancer. It is an investigational therapy in Phase 1 testing and is not yet approved for any indication. Its clinical program enrolls adults aged 18 years and older.
ERAS-801 targets EGFR, a protein receptor that is frequently altered in glioblastoma. By acting on this molecular target, the small molecule is intended to interfere with EGFR-driven signaling in tumor cells. EGFR is a validated oncology target across several cancer types.
ERAS-801 is being developed by Erasca, Inc., a biopharmaceutical company that trades under the ticker symbol ERAS. Erasca is running the clinical program for the drug in recurrent glioblastoma multiforme, with the Phase 1 trial conducted in the United States.
ERAS-801 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for glioblastoma multiforme or any other indication. The Phase 1 program is evaluating the drug in patients with recurrent glioblastoma.
ERAS-801 is being evaluated in the Phase 1 THUNDERBBOLT-1 trial, registered as NCT05222802. The study is titled a study to evaluate ERAS-801 in patients with recurrent glioblastoma and is currently active but not recruiting. It plans to enroll 52 patients in the United States.