Nader Sanai, MD
Largest Phase 0 Clinical Trials Program
Ivy Center team members will present new data from four early-phase clinical trials, and Nader Sanai, MD, Director of the Ivy Center and Chief of Neurosurgical Oncology at Barrow, will also discuss innovative pharmacodynamic and pharmacokinetic-driven clinical trial designs in neuro-oncology.
Promising results from the Ivy Center's Phase 0/1 clinical trial of BDTX-1535, an oral brain-penetrant 4th-generation EGFR inhibitor, demonstrated that the drug effectively penetrates rarely accessible regions of glioblastoma and suppresses EGFR signaling in patient tumors. These data provide rationale for the trial's expansion into newly diagnosed glioblastoma patients with EGFR aberrations.
The Ivy Center's multiple presentations at EANO represent a broad PK/PD clinical trial portfolio. Details are as follows:
Thursday, October 17
- 11:30 BST, Clinical Session: Innovative trial design in neuro-oncology
Presentation Title: Pragmatic PK/PD-driven clinical trial designs
- 9:15 BST, Oral Session: DNA repair inhibitors in glioma
Presentation Title: A Phase 0/1b study of AZD1390 plus radiotherapy in recurrent glioblastoma patients
Abstract Number: JS02.5.A
- 18:00 BST, Poster Presentation: Adult glioma
Presentation Title: Niraparib efficacy in patients with newly diagnosed glioblastoma: clinical readout of a Phase 0/2 'trigger' trial
Poster Number: P18.31.A
- 18:00 BST, Poster Presentation: Adult glioma
Presentation Title: De-novo purine metabolism can be targeted safely in glioblastoma treatment to overcome chemoradiation resistance: An interim result of phase 0/1 clinical trial
Poster Number: P18.13.A
- 11:15 BST, Oral Session: Highlights from clinical abstracts
Presentation Title: A Phase 0/1 'trigger' trial of BDTX-1535 in recurrent high-grade glioma patients with EGFR alterations or fusions
Abstract Number: OS06.9.A
These investigator-initiated and supported collaborative studies, which will be reported on at EANO, are funded by the Ben & Catherine Ivy Foundation and Barrow Neurological Foundation.
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About Ivy Brain Tumor Center
Ivy Brain Tumor Center at Barrow Neurological Institute in Phoenix, AZ, is a tertiary care and nonprofit translational research program that employs bold, early-phase clinical trial strategies to identify new treatments for aggressive brain tumors, including glioblastoma. Our leading experts in neurosurgical oncology, neuro-oncology, radiation oncology, neuroradiology, neuropathology and neuroscience nursing treat more patients annually than any other brain tumor center in the United States. The Ivy Center's Phase 0 clinical trials program is the largest in the world and enables personalized care in a fraction of the time and cost associated with traditional drug development. In addition, unlike conventional clinical trials focusing on single drugs, the Ivy Center's accelerated program tests therapeutic combinations matched to individual patients. We leave no stone unturned in the pursuit of hope and healing. Learn more at IvyBrainTumorCenter.org. Follow the Ivy Brain Tumor Center on Facebook, Instagram, Twitter, and LinkedIn.
About BDTX-1535
BDTX-1535 is an oral, brain-penetrant MasterKey inhibitor of oncogenic EGFR mutations in NSCLC, including classical mutations, non-classical mutations, and the C797S resistance mutation. BDTX-1535 is a fourth-generation tyrosine kinase inhibitor (TKI) that potently inhibits, based on preclinical data, more than 50 EGFR mutations expressed across a diverse group of patients with NSCLC in multiple lines of therapy. Based on preclinical data, BDTX-1535 also inhibits EGFR extracellular domain mutations and alterations commonly expressed in glioblastoma (GBM) and avoids paradoxical activation observed with earlier generation reversible TKIs. A "window of opportunity” trial of BDTX-1535 in patients with GBM is ongoing (NCT06072586) and a Phase 2 trial is ongoing in patients with NSCLC (NCT05256290).
Attachments
CONTACT: Melinda Langdon
Ivy Brain Tumor Center
