Clinical trial · no report yet · Phase 1/Phase 2
NCT05256290
Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
- NCT05256290 ↗
- Active not recruiting
- Black Diamond Therapeutics, Inc.
- 5 commentary sources found
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built. Commentary is thin so far, so the report would be short.
| Channel | Found | |
|---|---|---|
| X threads | 5 |
The trial
ClinicalTrials.gov- Official title
- A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer
- Phase
- Phase 1/Phase 2
- Status
- Active not recruiting
- Conditions
- Non-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
- Interventions
- silevertinib (BDTX-1535) monotherapy
- Arms
- Phase 1 Dose Escalation - Monotherapy (Recruitment Closed) · Experimental
- Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations · Experimental
- Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation · Experimental
- Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations · Experimental
- Enrollment
- 200 (estimated)
- Primary outcomes
- Phase 1 Dose Escalation: To determine the maximum tolerated dose (MTD), if one exists, and the preliminary recommended Phase 2 dose(s) (RP2D[s]) of silevertinib (BDTX-1535)
- Phase 2: To assess antitumor efficacy of silevertinib (BDTX-1535)
- Sponsor
- Black Diamond Therapeutics, Inc.
- Start
- Mar 31, 2022
- Primary completion
- Nov 3, 2025
- Results posted
- No
- Registry record
- NCT05256290 · updated Jul 22, 2026