Drugs / ERAS-801
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07089641 | Jul 2025 → Jul 2027 expected | IDH-wildtype glioblastoma, gliosarcoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06934889 | Apr 2025 → Apr 2028 expected | gliosarcoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05222802 | Feb 2022 → Aug 2025 overdue | glioblastoma | Katmai Pharmaceuticals Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-11-28 | Erasca, Inc. | Results Erasca Achieves Key Milestones for Naporafenib and ERAS-801 Programs and Extends Cash Runway erasca.com ↗
Completed dose escalation and identified MTD for ERAS-801, supporting enrollment of expansion cohorts in recurrent GBM |
| 2023-06-22 | Erasca, Inc. | Regulatory Erasca Granted FDA Orphan Drug Designation for CNS-Penetrant EGFR Inhibitor ERAS-801 for the Treatment of Malignant Glioma erasca.com ↗
today announced the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ERAS-801 for the treatment of malignant glioma, which includes glioblastoma (GBM). |
| 2023-05-01 | Erasca, Inc. | Regulatory Erasca Granted FDA Fast Track Designation for CNS-Penetrant EGFR Inhibitor ERAS-801 in Patients with Glioblastoma erasca.com ↗
Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ERAS-801 for the treatment of adult patients with glioblastoma (GBM) with epidermal growth factor receptor (EGFR) gene alterations. |
| 2022-10-12 | Erasca, Inc. | Results Erasca Announces Four Poster Presentations at the Upcoming 34th EORTC-NCI-AACR Symposium erasca.com ↗
CNS-penetrant EGFR inhibitor ERAS-801 demonstrates superior anti-tumor activity over osimertinib in preclinical model of EGFR mutant NSCLC with CNS metastases |
| 2021-12-17 | Erasca, Inc. | Regulatory Erasca Announces FDA Clearance of IND Application for ERAS-801 in Glioblastoma Multiforme and Collaboration with GCAR for Potential Inclusion in GBM AGILE Clinical Trial erasca.com ↗
Filing this IND a quarter ahead of schedule and receiving FDA clearance allows us to begin potentially helping patients sooner |
| 2021-10-25 | Erasca, Inc. | Results Erasca Announces Presentation of Preclinical Data on ERAS-801, a CNS-Penetrant EGFR Inhibitor with Broad Activity against Oncogenic EGFR Alterations, at AACR Conference on Brain Cancer erasca.com ↗
In more than 30 GBM patient-derived preclinical models, ERAS-801 demonstrated potent activity across mutant and wildtype oncogenic EGFR alterations, and we are highly encouraged by the extensive therapeutic potential of ERAS-801 for patients with this aggressive malignancy. |
All press releases naming this drug 6 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ERAS-801 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06934889 ↗ |
| Action | Inhibit | “EGFR/ERBB1 Inhibitor” NCT05222802 ↗ |
| Modality | Small molecule | — CHEMBL6068579 ↗ |
| Route | Oral | “Administered orally” NCT05222802 ↗ |
| Target | EGFR | “EGFR/ERBB1 Inhibitor” NCT05222802 ↗ |