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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 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 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 15 states.

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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.

Conditions Studied

Non-Small Cell Lung Cancer NSCLC Metastatic Lung Non-Small Cell Carcinoma Metastatic Lung Cancer Advanced Lung Carcinoma Advanced Non-Small Cell Squamous Lung Cancer Epidermal Growth Factor Receptor C797S Epidermal Growth Factor Receptor G719X EGF-R Positive Non-Small Cell Lung Cancer EGFR-TKI Resistant Mutation

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

FieldValue
Enrollment Target 200 participants
Start Date 2022-03-31
Est. Completion 2026-06
Phase Phase 1

Sponsor

Black Diamond Therapeutics

3 total trials

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What the Registry Record Tells You About NCT05256290

The ClinicalTrials.gov registry entry for NCT05256290 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (70% lower). The listed sponsor is Black Diamond Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.