Approval Probability
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Also known as silevertinib (BDTX-1535) monotherapy, silevertinib monotherapy
Silevertinib · 2 trials · 17 indications
Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.
Dose-limiting toxicities (DLTs) in Cycle 1
Objective response rate (ORR) as assessed by Investigator using RECIST version 1.1
| Arm | Type | Description |
|---|---|---|
| silevertinib and temozolomide | EXPERIMENTAL | silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles |
| temozolomide | ACTIVE_COMPARATOR | temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles |
| 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 in combination with temozolomide | DRUG | Participants enrolled into Part 1 (Safety Lead-In) or randomized to Arm A in Part 2 will receive silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles. |
| temozolomide (TMZ) | DRUG | Participants randomized to Arm B will receive temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles |
| 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. |
Key Inclusion Criteria: * Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT). * Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification). * For Part ...
Silevertinib is an investigational small molecule kinase inhibitor being developed by Black Diamond Therapeutics for the treatment of glioblastoma and non-small cell lung cancer. It is designed to target EGFR and is currently in Phase 2 clinical development. Silevertinib is also known as BDTX-1535.
Silevertinib is being studied for glioblastoma (GBM), including newly diagnosed GBM, and for non-small cell lung cancer (NSCLC) with EGFR mutations. It is an investigational therapy and has not been approved for any indication. Trials enroll adults 18 years and older.
Silevertinib targets EGFR, the epidermal growth factor receptor. It is a small molecule kinase inhibitor, part of the -tinib class. Its clinical program focuses on EGFR-mutant settings, including EGFRvIII in glioblastoma and mutations such as C797S, G719X, and EGFR-TKI resistance mutations in non-small cell lung cancer.
Silevertinib is developed by Black Diamond Therapeutics, Inc., which trades on the Nasdaq under the ticker BDTX. The company is running the clinical program for the drug in glioblastoma and non-small cell lung cancer.
Silevertinib is in Phase 2 clinical development. It is an investigational drug and is not FDA approved. The program includes a Phase 2 study in newly diagnosed glioblastoma and a Phase 1/2 study in glioblastoma or non-small cell lung cancer with EGFR mutations.
Silevertinib is being evaluated in two studies. NCT07326566 is a recruiting Phase 2 trial of silevertinib with temozolomide in newly diagnosed GBM with unmethylated MGMT and EGFRvIII, enrolling 162 patients in the United States. NCT05256290 is an active, not recruiting Phase 1/2 trial in glioblastoma or NSCLC with EGFR mutations, enrolling 200 patients.
Yes. Silevertinib is also known as BDTX-1535. The names refer to the same investigational EGFR-targeted kinase inhibitor from Black Diamond Therapeutics. Clinical study records and publications may use either silevertinib or BDTX-1535, including references to silevertinib monotherapy or silevertinib in combination with temozolomide.