CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 200 target
Drug / intervention
silevertinib (BDTX-1535) monotherapydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05256290
NCT05256290Phase 2ActiveUpdate OverdueUpdated 6mo ago · Completion was 7mo ago
Enrollment Stalled
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A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer

Black Diamond Therapeutics, Inc.·interventional·Posted Feb 25, 2022·Updated Dec 9, 2025

In Brief

A Phase 2 clinical trial evaluating silevertinib (BDTX-1535) monotherapy for Non-Small Cell Lung Cancer and 9 related conditions. Active but no longer recruiting, targeting 200 participants across 25 sites.

Signals

Enrollment appears stalled

Detailed Summary

BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently ongoing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, NSCLC, Advanced Lung Carcinoma, Epidermal Growth Factor Receptor C797S, Epidermal Growth Factor Receptor G719X, EGF-R Positive Non-Small Cell Lung Cancer, EGFR-TKI Resistant Mutation
CountriesUnited States
Collaborators--

Timeline

Phase 2ActiveOverdue
2023202420252026
First PostedFeb 25, 2022
Enrollment StartMar 31, 2022
Primary CompletionNov 3, 2025
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 4.4 years ago

Interventions

silevertinib (BDTX-1535) monotherapydrug

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.