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Testing BDTX-1535 for patients with glioblastoma or lung cancer with specific EGFR mutations

A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer

Phase1; Phase2 Interventional Black Diamond Therapeutics, Inc. · NCT05256290

This study is testing a new oral treatment called BDTX-1535 for patients with advanced lung cancer or glioblastoma that have certain mutations to see how well it works and what the best dose is.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorBlack Diamond Therapeutics, Inc. Industry-sponsored
Drugs / interventionsosimertinib, erlotinib, gefitinib, chemotherapy, radiation
Locations42 sites (Birmingham, Alabama and 41 other locations)
Trial IDNCT05256290 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of BDTX-1535, a new treatment for patients with advanced non-small cell lung cancer (NSCLC) or glioblastoma that have specific mutations in the epidermal growth factor receptor (EGFR). The study is divided into two phases, with Phase 1 focusing on dose escalation and Phase 2 assessing the treatment's antitumor activity in multiple cohorts. Participants will take BDTX-1535 orally in 21-day cycles, and the trial aims to determine the optimal dosage and pharmacokinetics of the drug. Enrollment for Phase 1 is complete, and Phase 2 is currently open for new participants.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic NSCLC or glioblastoma who have specific EGFR mutations and have experienced disease progression after standard therapies.

Not a fit: Patients with small cell lung cancer or those who have not received prior treatment for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with resistant forms of lung cancer and glioblastoma.

How similar studies have performed: Other studies targeting EGFR mutations in lung cancer have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Phase 2 Eligibility:

Key Inclusion Criteria Required for locally advanced or metastatic NSCLC:

* Measurable disease by RECIST 1.1 criteria.
* Adequate bone marrow or organ function.
* Life expectancy of ≥ 3 months.
* Sufficient performance status.
* Confirmed NSCLC, without small cell lung cancer transformation with or without brain metastases.
* Disease progression following or intolerance of standard of care (excluding patients in the treatment-naïve non-classical driver cohort):

  * Cohort 1 (Non-Classical driver cohort): Advanced/metastatic NSCLC with a non-classical driver EGFR mutation (eg, G719X) following up to 2 lines of therapy with only 1 prior EGFR TKI regimen (third-generation preferred; other approved EGFR TKI acceptable).
  * Cohort 2 (Acquired resistance C797S cohort): Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only one EGFR TKI, which must be a third generation EGFR TKI (eg, osimertinib).
  * Cohort 3 (First-line non-classical driver cohort): Treatment-naïve advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted). Patients with co-occurring L858R mutations and a non-classical mutation are eligible for inclusion.
* Identification of one (or more) of the following EGFR mutations by Next Generation Sequencing (NGS) as determined by a local assay performed in a validated laboratory in the absence of other known resistance mutations (eg, T790M, MET):

  * Non-classical driver EGFR mutations (eg, L861R, S768I, G719X).
  * EGFR acquired resistance mutation (eg, C797S) to a 3rd generation EGFR TKI.
  * For Phase 2, dose expansion, patients in Cohort 1 who received 3rd generation EGFR TKI (eg, osimertinib), the NGS report within 6 months prior to the start of Screening is acceptable. For patients in Cohort 2, the NGS report must be from the last disease progression on the immediate prior therapy. For patients in Cohort 3, the NGS report must be at the time of diagnosis.

Key Exclusion Criteria:

* Known resistant mutations in tumor tissue or by liquid biopsy (eg, T790M, MET).
* Received more than 1 EGFR TKI therapy (ie, erlotinib or gefitinib) for the treatment of metastatic or recurrent EGFR NSCLC.
* Any history of interstitial lung disease related to EGFR TKI use.
* Symptomatic or radiographic leptomeningeal disease.
* Symptomatic brain metastases or spinal cord compression requiring urgent clinical intervention.
* Unresolved toxicity from prior therapy.
* Significant cardiovascular disease.
* Major surgery within 4 weeks of study entry or planned during study.
* Ongoing or recent anticancer therapy or radiation therapy.
* Evidence of malignancy (other than study-specific malignancies) requiring active therapy within the next 2 years.
* Active hepatitis B or C infection and/or known human immunodeficiency virus (HIV) carrier.
* Poorly controlled gastrointestinal disorders.

Where this trial is running

Birmingham, Alabama and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerAdvanced Non-Small Cell Squamous Lung CancerMetastatic Lung Non-Small Cell CarcinomaMetastatic Lung CancerNSCLCAdvanced Lung CarcinomaEpidermal Growth Factor Receptor C797SEpidermal Growth Factor Receptor G719X
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.