About the study

This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of BDTX-1535 in patients with GBM or NSCLC harboring sensitive EGFR alterations and who have disease progression following standard of care

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Histologically confirmed diagnosis of GBM according to 2021 WHO criteria IDHwt (wild-type IDH) GBM and astrocytoma with molecular features of GBM).
2. A radiological diagnosis of recurrent disease following available standard of care therapy of surgery, radiation, and/or TMZ. Disease may be evaluable or measurable for dose escalation cohorts but must be measurable by RANO criteria for enrollment on the disease specific expansion.
3. Tumor evidence of EGFR alterations including amplification, variants, or mutations as determined in a local laboratory by NGS, RNAseq, FISH, IHC, or Array GCH Inclusion Criteria Required for NSCLC Patients Only:
4. Patients with NSCLC must meet all of the following inclusion criteria, in addition to the common inclusion criteria applicable for all patients:
5. Histologically or cytologically confirmed NSCLC, without small cell lung cancer transformation.
6. Locally advanced or metastatic disease, with or without CNS metastases. Disease may be evaluable or measurable for dose escalation cohorts but must be measurable by RECIST v1.1 criteria for enrollment on the disease specific expansion cohorts.
7. Disease progression following or intolerance of standard of care:
8. NSCLC with uncommon EGFR mutations (eg, G719X), following standard of care therapy with an EGFR inhibitor.
9. 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).
10. EGFR mutations identified by NGS in the absence of other known resistance mutations (eg, T790M, MET) Common

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.