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

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.

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

This part of the study will start with two dose levels (100mg and 200mg) which did not have any major side effects in Phase 1 Dose Escalation cohorts. Up to the first 40 participants (in Cohorts 1 and 2) will be randomly assigned (50% chance, like the flip of a coin) to one of the two dose levels. You will have an equal chance of being assigned to each dose level. Your study doctor will tell you which dose level you have been assigned.

The study regimen will be given in cycles. In the monotherapy cohort, each cycle is 21 days.  Participants will take the study drug tablets every day by mouth. The study drug will be taken in the morning with about 8 oz water. Participants will not eat for at least 2 hours before and 1 hour after each dose. The study drug must not be crushed or chewed or dissolved in water in order to take it.