RecruitingEarly Phase 1NCT06072586

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

A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-triggered Expansion Cohort


Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Enrollment

82 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BDTX-1535 for people with brain tumors — either glioblastoma newly diagnosed or high-grade glioma that has come back after treatment — that have specific changes (mutations or fusions) in the EGFR gene. The drug is designed to cross the blood-brain barrier and target these specific genetic changes. **You may be eligible if...** - You have recurrent high-grade brain tumor (grades 3 or 4) that progressed after standard treatment, OR - You have newly diagnosed glioblastoma not yet treated beyond surgery or biopsy - Your tumor has a specific EGFR alteration or fusion confirmed by tissue testing - You are a candidate for surgery to remove or biopsy the tumor **You may NOT be eligible if...** - You have received prior treatment with certain EGFR-targeting drugs - You have serious organ problems or poor functional status - You cannot have the required surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBDTX-1535

BDTX-1535 is an inhibitor of EGFR mutations

DRUGBDTX-1535 combined with radiation therapy

During Phase 1, BDTX-1535 concurrently with standard of care upfront RT, followed by adjuvant monotherapy with BDTX-1535 continuously in 28-day cycles after RT.

DRUGBDTX-1535 combined with temozolomide and radiation therapy

During Phase 1, BDTX-1535 concurrently with standard of care upfront RT and TMZ, followed by adjuvant BDTX-1535 combined with standard of care TMZ continuously in 28-day cycles after RT.


Locations(2)

Chandler Regional Medical Center

Chandler, Arizona, United States

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06072586


Related Trials