Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
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

Led by St. Joseph's Hospital and Medical Center, Phoenix · Updated on 2025-11-20

82

Participants Needed

2

Research Sites

215 weeks

Total Duration

On this page

Sponsors

S

St. Joseph's Hospital and Medical Center, Phoenix

Lead Sponsor

I

Ivy Brain Tumor Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of recurrent high-grade glioma (WHO Grades 3 and 4) that has progressed after standard therapy including surgery, temozolomide, and radiotherapy (Arms A & B)
  • Newly diagnosed glioblastoma (WHO Grade 4) with no prior tumor treatment except biopsy or resection (Arms C, D & E)
  • Candidate for surgical tumor resection
  • Availability of tumor tissue showing EGFR alterations such as variants, fusions, or mutations, with or without amplifications
  • Measurable disease with at least one contrast-enhancing lesion measuring 1 cm or more in two directions
  • Signed informed consent prior to study procedures
  • ECOG performance status of 0, 1, or 2
  • Ability to swallow oral medications
  • Adequate bone marrow and organ function per specified laboratory values
  • Stable or decreasing corticosteroid use for at least 5 days before treatment
  • Negative pregnancy test or no longer of childbearing potential
  • Use of effective contraception during treatment and for 16 weeks after last dose
  • Agreement to follow lifestyle considerations throughout the study
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Known allergy to BDTX-1535 components
  • Active or uncontrolled severe infection or liver disease
  • Active systemic bacterial, fungal, or viral infections requiring treatment or with fever over 38.56C
  • Significant heart disease or recent cardiac events within 6 months
  • Symptomatic or radiographic leptomeningeal disease
  • Serious or uncontrolled preexisting medical conditions that could interfere with study participation
  • Concurrent use of strong CYP2C8 or CYP3A4 inhibitors or inducers not discontinued before study start
  • Use of other investigational drugs within 5 half-lives before starting the study
  • Unresolved toxicities from prior treatments greater than Grade 1 (except alopecia), with discussion needed for Grade 2 toxicities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Chandler Regional Medical Center

Chandler, Arizona, United States, 85224

Actively Recruiting

2

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States, 85013

Actively Recruiting

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Research Team

P

Phase 0 Navigator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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