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NCT05256290 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
A Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by Black Diamond Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05256290: Active Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by Black Diamond Therapeutics.
NCT05256290 is a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC that is active but no longer recruiting, run by Black Diamond Therapeutics. The registered enrollment target is 200 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05256290, a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, is active but no longer recruiting, sponsored by Black Diamond Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Dose-limiting toxicities (DLTs) in Cycle 1
Conditions Studied
Interventions
- DRUG silevertinib (BDTX-1535) monotherapy
Study Locations (20)
California
- City of Hope Huntington Beach - Huntington Beach
- City of Hope Orange County Lennar Foundation Cancer Center - Irvine
- Cedars Sinai Medical Center - Los Angeles
New York
- Memorial Sloan Kettering Cancer Center - New York
- Columbia University Irving Medical Center - New York
- Montefiore Medical Center - The Bronx
Florida
- Mayo Clinic- Jacksonville - Jacksonville
- Miami Cancer Institute - Baptist Health South Florida - Miami
Alabama
- University of Alabama - Birmingham
Arizona
- Banner MD Anderson Cancer Center - Gilbert
District of Columbia
- Sibley Memorial Hospital Johns Hopkins Medicine - Washington D.C.
Hawaii
- UHP- University of Hawaii Cancer Center - Honolulu
Illinois
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What the registry record for NCT05256290 still lists
NCT05256290 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (69% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which silevertinib (BDTX-1535) monotherapy is the first listed.
NCT05256290 names 20 study sites across 15 states, led by California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT05256290 about?
NCT05256290 is a clinical study titled "Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations". 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 eith...
What is the current status of trial NCT05256290?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2022-03-31. Estimated completion is 2026-06.
What conditions does trial NCT05256290 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, NSCLC, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, Advanced Lung Carcinoma.
What interventions are being tested in trial NCT05256290?
The interventions under investigation include: silevertinib (BDTX-1535) monotherapy (DRUG).
Who is sponsoring clinical trial NCT05256290?
This trial is sponsored by Black Diamond Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05256290 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05256290's enrollment target sits among peer trials
200 164th of 454 higher than 288 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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