A Phase 1 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma or Non-Small Cell Lung Cancer
Trial Description: BDTX-1535-101 is a first-in-human, open-label, Phase 1 dose escalation and multiple expansion cohort study designed to evaluate the safety, tolerability, pharmacokinetics (PK), central nervous system (CNS) activity, and preliminary antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) harboring sensitive epidermal growth factor receptor (EGFR) mutations with or without CNS disease, or glioblastoma multiforme (GBM) expressing EGFR alterations. All patients will self administer BDTX-1535 monotherapy in 21-day cycles. One expansion cohort will include patients with newly diagnosed GBM who will self administer BDTX-1535 in combination with temozolomide in 28-day cycles.
- Conditions: advanced lung carcinoma, advanced non-small cell squamous lung cancer, advanced solid tumor, egfr gene mutation, gbm, glioblastoma, metastatic cancer, metastatic lung cancer, metastatic lung non-small cell carcinoma, new diagnosis tumor, non-small cell lung cancer, nsclc, recurrent glioblastoma
- Phase: I
- Trial ID: NCT05256290
- Protocol ID: 22-295