Drugs / silevertinib
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06072586 | Oct 2023 → Dec 2026 expected | glioblastoma | St. Joseph's Hospital and Medical Center, Phoenix | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05256290 | Mar 2022 → Nov 2025 overdue | non-small cell squamous lung carcinoma | Black Diamond Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07326566 | May 2026 → Nov 2028 expected | brain cancer, glioblastoma | Black Diamond Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Black Diamond Therapeutics, Inc. | Results Black Diamond Therapeutics Announces Positive Phase 2 Results for Silevertinib in Frontline NSCLC Patients with EGFR Non-Classical Mutations blackdiamondtherapeutics.com ↗
today announced positive results from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations (NCMs). |
| 2025-12-03 | Black Diamond Therapeutics, Inc. | Results Black Diamond Therapeutics Announces Preliminary Phase 2 Data for Silevertinib in 1L NSCLC and Plans for a Phase 2 Trial of Silevertinib in GBM blackdiamondtherapeutics.com ↗
Silevertinib delivers robust anti-tumor activity as demonstrated by an ORR of 60% and a CNS response rate of 86% in 43 1L NSCLC patients presenting with 35 different non-classical EGFR mutations; no new safety signals observed to date |
| 2024-09-23 | Black Diamond Therapeutics, Inc. | Results Black Diamond Therapeutics Announces Initial Phase 2 Data Demonstrating Robust Anti-tumor Activity of BDTX-1535 in Patients with Recurrent EGFRm NSCLC who Present with a Broad Spectrum of Classical, Non-classical, and C797S Resistance Mutations blackdiamondtherapeutics.com ↗
Our preliminary Phase 2 data demonstrate the potential of BDTX-1535 to deliver durable responses for these patients. |
| 2024-06-01 | Black Diamond Therapeutics, Inc. | Results Black Diamond Therapeutics Presents Promising BDTX-1535 Clinical Data in Patients with Recurrent Glioblastoma at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting blackdiamondtherapeutics.com ↗
In addition, the Phase 1 trial demonstrated encouraging anti-tumor activity and duration of treatment for patients with previously treated GBM. |
| 2023-12-13 | Black Diamond Therapeutics, Inc. | Results Black Diamond Therapeutics Announces Topline Results from Phase 1 Dose Escalation Trial of BDTX-1535 in Patients with Recurrent GBM blackdiamondtherapeutics.com ↗
Initial results show promising clinical activity in heavily pretreated patients |
| 2023-10-14 | Black Diamond Therapeutics, Inc. | Results Black Diamond Therapeutics Presents Dose Escalation Data Demonstrating Durable Responses in Patients with NSCLC from Phase 1 Trial of BDTX-1535 blackdiamondtherapeutics.com ↗
today presented results demonstrating encouraging response durability of BDTX-1535 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). |
| 2023-06-27 | Black Diamond Therapeutics, Inc. | Results Black Diamond Therapeutics Announces Initial Dose Escalation Data Demonstrating Anti-Tumor Activity of BDTX-1535 in Non-Small Cell Lung Cancer Patients Across Multiple EGFR Mutation Families blackdiamondtherapeutics.com ↗
BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, demonstrates clinical proof of activity for MasterKey mutation-targeting approach based on radiographic tumor responses and circulating tumor DNA changes in NSCLC patients with acquired resistance and intrinsic driver EGFR mutations |
All press releases naming this drug 15 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | silevertinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05256290 ↗ |
| Known as | BDTX-1535 | “designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535)” NCT05256290 ↗ |
| Action | Inhibit | “4th generation irreversible brain penetrant EGFR MasterKey inhibitor” NCT05256290 ↗ |
| Route | Oral | “All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth” NCT05256290 ↗ |
| Target | EGFR | “targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC” NCT05256290 ↗ |