BDTX-1535 in Non-Small Cell Lung Cancer

What is the Purpose of this Study?

The purpose of this study is to evaluate an experimental drug called BDTX-1535 in patients with non-small cell lung cancer. BDTX-1535 is being tested to help patients with advanced solid tumors with changes in a protein named epidermal growth factor receptor (EGFR). The study aims to determine how often and how much of the study drug should be given to cancer patients, the side effects of the drug, and how long after dosing it remains in the body. Researchers also want to learn how BDTX-1535 affects biomarkers, which are substances in the body that can be measured to help track the status of disease. In addition to taking BDTX-1535, study procedures include medical history review, collection of vital signs, electrocardiograms, physical exams, echocardiograms, imaging, blood draws, eye exam, and questionnaires.

Eligibility

Phase 2 Eligibility:
* Measurable disease by RECIST 1.1 criteria.
* Adequate bone marrow or organ function.

Phase 2 Eligibility:
* 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.

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Where can I participate?

CS Cancer Tarzana : Garrett Crook
CS Cancer at Beverly Hills : Garrett Crook
CS Cancer at Cedars-Sinai Medical Center : Garrett Crook
Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer

More about this Clinical Trial

What is the full name of this clinical trial?

BDTX-1535-101: A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma or Non-Small Cell Lung Cancer

Study Details

Disease Type/Condition

Brain and Nervous System, Lung

Principal Investigator

Sankar, Kamya

Co-Investigators

Amin Mirhadi, Andrew Horodner, Ani Balmanoukian, David Chan, David Hoffman, Hugo Hool, Jeremy Lorber, Justin Wayne Tiulim, Karen Reckamp, Kevin Scher, Navid Hafez, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey

Age Group

Adult

Phase

I/II

IRB Number

STUDY00003472

ClinicalTrials.gov ID

NCT05256290

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Garrett Crook

Garrett.Crook@cshs.org