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

Description

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 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 BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently enrolling.

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

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Study Overview

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Study Details

Study overview

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 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 BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently enrolling.

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

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

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35294

Beverly Hills

Beverly Hills Cancer Center, Beverly Hills, California, United States, 90211

Duarte

City of Hope Comprehensive Cancer Center (Duarte Campus), Duarte, California, United States, 91010

Huntington Beach

City of Hope Huntington Beach, Huntington Beach, California, United States, 92648

Irvine

City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California, United States, 92618

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Denver

HealthOne Denver, Denver, Colorado, United States, 80218

Washington

Johns Hopkins Bayview Medical Center, Washington, District of Columbia, United States, 20016

Washington

Sibley Memorial Hospital Johns Hopkins Medicine, Washington, District of Columbia, United States, 20016

Miami

Baptist Health Miami, Miami, Florida, United States, 33176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Black Diamond Therapeutics, Inc.,

Black Diamond Therapeutics, STUDY_DIRECTOR, Black Diamond Therapeutics

Study Record Dates

2026-06