Silevertinib
Silevertinib is an experimental small-molecule drug from Black Diamond Therapeutics in phase 2 trials for non-small-cell lung cancer, aimed at EGFR.
Overview
Silevertinib (BDTX-1535) is a small-molecule drug developed by Black Diamond Therapeutics. Its target is EGFR (the sponsor names EGFR). The sponsor states: A first and best-in-class 4th generation, brain-penetrant, irreversible EGFR inhibitor designed to address classical and non-classical EGFR driver and resistance mutations in NSCLC and glioblastoma. ClinicalTrials.gov describes the intervention as: 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. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, in non-small-cell lung cancer. The largest, NCT05256290, plans to enrol 200 participants with primary completion expected 2025-11-03. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas · Lines of therapy.
Trials
topTrials recruiting now
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Latest papers
topQuery for this drug: (TITLE:"Silevertinib" OR ABSTRACT:"Silevertinib" OR TITLE:"BDTX-1535" OR ABSTRACT:"BDTX-1535" OR TITLE:"silevertinib BDTX-1535" OR ABSTRACT:"silevertinib BDTX-1535") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Silevertinib, not a curated reading list.
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