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ACTIVE NOT RECRUITING Phase 1

Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

NCT05256290 · View on ClinicalTrials.gov ↗

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.

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

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05256290

The ClinicalTrials.gov registry entry for NCT05256290 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Black Diamond Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05256290 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05256290?

The interventions under investigation include: silevertinib (BDTX-1535) monotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05256290?

This trial is sponsored by Black Diamond Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial