OncoMatch/Clinical Trials/NCT06072586
A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions
Is NCT06072586 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including BDTX-1535 and BDTX-1535 combined with radiation therapy for high grade glioma.
Treatment: BDTX-1535 · BDTX-1535 combined with radiation therapy · BDTX-1535 combined with temozolomide and radiation therapy — This study will administer the investigational drug, BDTX-1535 to eligible patients with recurrent high-grade glioma (HGG) and newly-diagnosed glioblastoma (nGBM). BDTX-1535 was designed to block a growth signal important to some cancers. BDTX-1535 is being tested in this study to see if it can be given safely to people who have tumors that can be dependent on that growth signal because of changes in a protein called EGFR. These gene changes are called amplifications, mutations, fusions or alterations and are found only in the tumors. The study design includes a Phase 0 component with PK/PD-trigger for participant enrollment into an Expansion Phase 1 component. The primary objective of the Phase 0 component is to evaluate the PK endpoints of BDTX-1535. The primary objective of the Phase 1 component is to establish the safe dose of BDTX-1535 to be used in participants with a specified treatment regimen, three of which include standard of care radiotherapy for nGBM participants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: EGFR alteration
EGFR alterations including variants, fusion, and mutations with or without amplifications
Required: EGFR fusion
EGFR alterations including variants, fusion, and mutations with or without amplifications
Required: EGFR amplification
EGFR alterations including variants, fusion, and mutations with or without amplifications
Disease stage
Required: Stage 2021 WHO GRADE 3, 2021 WHO GRADE 4 (2021 WHO)
Recurrent high grade glioma (2021 WHO Grades 3 and 4)... Newly diagnosed glioblastoma (2021 WHO Grade 4)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: maximal surgical resection — standard therapy for rHGG
progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy
Must have received: temozolomide (temozolomide) — standard therapy for rHGG
progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy
Must have received: fractionated radiotherapy — standard therapy for rHGG
progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL (at time of surgery); Hemoglobin ≥ 8.5 g/dL (transfusions permitted)
Kidney function
Serum creatinine ≤ 1.5 X ULN or estimated creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin ≤ 1.5 X ULN (Gilbert's syndrome ≤ 3.0 X ULN and direct bilirubin within normal limits permitted); AST (SGOT) ≤ 3 X institutional ULN; ALT (SGPT) ≤ 3 X institutional ULN
Participant has adequate bone marrow and organ function as defined by the following laboratory values...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Chandler Regional Medical Center · Chandler, Arizona
- St. Joseph's Hospital and Medical Center · Phoenix, Arizona
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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