Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as silevertinib (BDTX-1535) monotherapy
silevertinib monotherapy · 1 trial · 10 indications
Dose-limiting toxicities (DLTs) in Cycle 1
Objective response rate (ORR) as assessed by Investigator using RECIST version 1.1
| Arm | Type | Description |
|---|---|---|
| Phase 1 Dose Escalation - Monotherapy (Recruitment Closed) | EXPERIMENTAL | * Advanced/metastatic NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M). * Advanced/metastatic NSCLC with non-classical EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor * Recurrent GBM with confirmed EGFR alterations (including amplification, mutation, and/or variant) |
| Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations | EXPERIMENTAL | Advanced/metastatic NSCLC with a non-classical driver EGFR mutation following up to 2 lines of therapy with only 1 prior EGFR targeted regimen (third-generation preferred; other approved EGFR inhibitors acceptable) |
| Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation | EXPERIMENTAL | Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only 1 EGFR targeted regimen, which must be a third generation EGFR TKI (eg, osimertinib) |
| Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations | EXPERIMENTAL | Treatment-naïve (first-line) advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted). Patients with co-occurring L858R mutations and a non-classical mutation are eligible for inclusion. |
| Name | Type | Description |
|---|---|---|
| silevertinib (BDTX-1535) monotherapy | DRUG | Silevertinib (BDTX-1535) is a 4th generation irreversible brain penetrant EGFR MasterKey inhibitor, which targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC. |
Phase 2 Eligibility: Key Inclusion Criteria Required for locally advanced or metastatic NSCLC: * Measurable disease by RECIST 1.1 criteria. * Adequate bone marrow or organ function. * Life expectancy of ≥ 3 months. * Sufficient performance status. * Confirmed NSCLC, without small cell lung cancer ...
Top 20 of 84 competitors
Silevertinib monotherapy is an investigational small molecule being studied for Non-Small Cell Lung Cancer (NSCLC), including advanced and metastatic forms. It is also being evaluated in glioblastoma. The drug is in Phase 1 clinical development and is not yet approved by the FDA.
Silevertinib is a kinase inhibitor, a type of targeted therapy that blocks specific enzymes involved in cancer cell growth. It is being studied in patients with EGFR mutations, including the C797S and G719X mutations, which are associated with resistance to earlier EGFR-targeted treatments.
Silevertinib is being developed by Black Diamond Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BDTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with EGFR-mutant cancers.
Silevertinib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1/2 study is actively enrolling or has enrolled patients, but the drug is not yet available commercially.
Silevertinib is being studied in a Phase 1/2 clinical trial identified as NCT05256290. This trial is evaluating the drug in patients with glioblastoma or Non-Small Cell Lung Cancer with EGFR mutations. The study is active but not recruiting, with an estimated enrollment of 200 participants in the United States.
Yes, silevertinib is also known as BDTX-1535. In clinical trial records, the drug is referred to as silevertinib (BDTX-1535). It is being studied as a monotherapy and in combination with temozolomide, though the current trial focuses on monotherapy.