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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 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 designed for patients with specific EGFR mutations, such as the C797S and G719X mutations, and for those resistant to EGFR-TKI therapy.
Silevertinib targets EGFR, the epidermal growth factor receptor, a kinase involved in cell growth. As a -tinib class kinase inhibitor, it is being developed to address EGFR mutations like C797S and G719X in Non-Small Cell Lung Cancer. The drug aims to inhibit mutant EGFR signaling in tumors that have developed resistance to earlier EGFR-targeted therapies.
Silevertinib is being developed by Black Diamond Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker BDTX. The company is conducting clinical research on this investigational drug for Non-Small Cell Lung Cancer and glioblastoma.
Silevertinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1/2 study is currently active but not recruiting participants, and it is evaluating the drug in patients with glioblastoma or Non-Small Cell Lung Cancer with EGFR mutations.
Silevertinib is being studied in a single clinical trial registered as NCT05256290. This Phase 1/2 study enrolls patients with glioblastoma or Non-Small Cell Lung Cancer with EGFR mutations, including advanced squamous lung cancer and metastatic disease. The trial is active in the United States and targets approximately 200 participants aged 18 and older.
Yes, silevertinib is also known as BDTX-1535. The drug is referred to as silevertinib (BDTX-1535) in clinical research. It is being studied as a monotherapy and in combination with temozolomide, though the current trial focuses on monotherapy for EGFR-mutant cancers.