Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Brain Tumor Lung Cancer	NCT ID:	NCT05256290
Trial Phases:	Phase I Phase II	Protocol IDs:	BDTX-1535-101 (primary) NCI-2022-04465
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Black Diamond Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05256290

Summary

BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study
designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous
system (CNS) activity, and antitumor activity of BDTX-1535. The study population
comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with
non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S)
mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM)
expressing EGFR alterations (Phase 1 only). All patients will self-administer BDTX-1535
monotherapy by mouth in 21-day cycles.

Phase 1 enrollment is now complete. Phase 2 is currently enrolling.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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