A Phase 1 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma or Non-Small Cell Lung Cancer
A Phase 1 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma or Non-Small Cell Lung Cancer
NCT #
NCT05256290
Condition(s)
GBM (Glioblastoma), Non-Small Cell Lung
Molecular Target(s)
EGFR
Drug Classification(s)
Small Molecule (Targeted)
Agents(s)
BDTX-1535
Phase(s)
I
Mechanism of Action
BDTX-1535 selectively targets, irreversibly binds to, and inhibits the activity of various EGFR alterations and mutations. This prevents EGFR-mediated signaling in susceptible tumor cells. This may both induce cell death and inhibit tumor growth in EGFR-overexpressing tumor cells.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of the study drug can be given with an acceptable level of side effects
- The effects of the study drug (good and bad)
- How much of the study drug is absorbed into the blood and how fast it is removed with and without food
- If research tests can be used in the future to predict who will benefit from BDTX-1535
- How the study drug is acting on your body
- Required for ALL Patients:
- Evaluable or measurable disease in dose escalation and measurable disease only for dose expansion cohorts.
- Fulfills appropriate disease criteria as defined in Arms and Interventions
- Adequate bone marrow or organ function.
- Life expectancy of ≥ 3 months.
- Sufficient performance status.
- Inclusion Criteria Required for NSCLC Patients Only:
- Confirmed NSCLC, without small cell lung cancer transformation.
- Locally advanced or metastatic disease, with or without central nervous system metastases.
- Disease progression following or intolerance of standard of care:
- Dose escalation cohorts only:
- NSCLC with uncommon EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor.
- NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M).
- Dose expansion cohorts only:
- NSCLC with intrinsic resistance EGFR mutation (eg, L858R, G719X) with up to 2 lines of standard-of-care therapy with an EGFR inhibitor.
- NSCLC with acquired resistance EGFR mutation (eg, C797S) with up to 2 lines of therapy, the first line of which must be a 3rd generation EGFR inhibitor (in the absence of concurrent T790M). Note: therapies targeted for 3rd generation EGFR tyrosine kinase resistance are excluded for this patient population.
- Identification of one (or more) EGFR mutations identified in the absence of other known resistance mutations:
- Intrinsic resistance EGFR mutations [eg, L858R [dose expansion only], G719X).
- EGFR acquired resistance mutation (eg, C797S) to a 3rd generation EGFR inhibitor.
- Inclusion Criteria Required for All GBM Patients Only:
- Confirmed diagnosis of GBM.
- Tumor evidence of EGFR alterations including variants, or mutations with or without amplifications (eg, A289T/V, G598V, S645C).
- Inclusion Criteria Required for Recurrent GBM Patients Only:
- Disease progression after treatment with available therapies or who refuse or are intolerant to treatment.
- Radiological diagnosis of recurrent disease following available standard-of-care therapy of surgery, radiation, and/or temozolomide.
- Inclusion Criteria Required for Newly Diagnosed GBM Patients Only:
- Recovered from maximal debulking surgery (gross total resection or partial resection are also acceptable).
- Received radiation therapy and temozolomide at least 6 weeks, but no more than 8 weeks, prior to Cycle 1 Day 1.
- Known resistant mutations.
- For GBM patients only: treated with a prior EGFR inhibitor.
- 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.
- Ongoing or recent 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.
Dose escalation cohorts only:
- NSCLC with intrinsic resistance EGFR mutation (eg, L858R, G719X) following a 3rd generation EGFR inhibitor treatment.
- NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M)
Dose expansion cohorts only:
- NSCLC with intrinsic resistance EGFR mutation (eg, L858R, G719X) with up to 2 lines of therapy, one of which must be a 3rd generation EGFR inhibitor treatment.
- NSCLC with acquired resistance EGFR mutation (eg, C797S) with up to 2 lines of therapy, the first line of which must be a 3rd generation EGFR inhibitor (in the absence of concurrent T790M). Note: therapies targeted for 3rd generation EGFR TKI resistance are excluded for this patient population.
Location
MCD
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