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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Rozpoznanie nawrotu glejaka mózgu wysokiego stopnia (grupy 3-4 WHO) lub nowo wykryty glejak czuł (grupa 4 WHO)
- •Wcześniejsze leczenie obejmujące operację, chemioterapię i radioterapię (dla nawrotów) lub jedynie biopsję/resekcję (dla nowych przypadków)
- •Guz zawiera zmiany genetyczne w białku EGFR (mutacje, fuzje lub wzmocnienia)
- •Guz widoczny w badaniach obrazowych - co najmniej 1 cm wielkości
- •Wiek co najmniej 18 lat
- •Ogólny stan zdrowia pozwalający na uczestniczenie w badaniu (skala ECOG ≤ 2)
- •Zdolność do połykania leków doustnych
- •Zadowalające wyniki badań krwi (liczba białych krwinek, płytki, hemoglobina, funkcja wątroby i nerek)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 16, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Chandler Regional Medical Center
Chandler, United States
St. Joseph's Hospital and Medical Center
Phoenix, United States
Trial contact
Phase 0 Navigator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/17/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.