Actively Recruiting
A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma and Newly Diagnosed Glioblastoma Participants With EGFR Alterations or Fusions Scheduled for Tumor Resection to Evaluate Central Nervous System Penetration
Led by St. Joseph's Hospital and Medical Center, Phoenix · Updated on 2025-11-20
82
Participants Needed
2
Research Sites
52 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
Researchers are evaluating an investigational drug called BDTX-1535 in people with recurrent high-grade glioma (HGG) and newly diagnosed glioblastoma (nGBM) who have specific changes in a protein called EGFR found only in their tumors. This study includes a Phase 0 part to assess how the drug behaves in the body and a Phase 1 part to find the safe dose and treatment regimen, some of which include standard radiotherapy. The study aims to understand if BDTX-1535 can be safely given to these participants based on their tumor's genetic profile. In the Phase 0 component, participants receive BDTX-1535 before planned tumor removal surgery, with doses varying by group and timing designed to measure drug levels in blood, tumor, and cerebrospinal fluid. After surgery, those showing specific responses continue in the Phase 1 expansion, receiving daily BDTX-1535 in 28-day cycles, sometimes combined with radiation therapy or temozolomide depending on tumor characteristics. Treatment continues until disease progression, unacceptable side effects, or other reasons such as withdrawal or study end. Participants will have surgery with sample collection for drug level and protein activity analysis, followed by regular treatment visits during Phase 1. Researchers will monitor safety, side effects, and lab values, along with progression-free and overall survival for up to 12 months after surgery. The study includes frequent assessments and safety follow-up to evaluate how the drug interacts with tumors and its tolerability over time.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of recurrent high-grade glioma (WHO Grades 3 and 4) who have progressed after standard therapy including surgery, temozolomide, and radiotherapy (Arms A & B)
- Diagnosis of newly diagnosed glioblastoma (WHO Grade 4) with no prior tumor-directed treatment except biopsy or resection (Arms C, D & E)
- Candidate for clinical resection of recurrent or newly diagnosed glioma
- Availability of tumor tissue showing EGFR alterations, including variants, fusion, or mutations
- Measurable disease preoperatively with at least 1 contrast-enhancing lesion measuring at least 1 cm in two perpendicular dimensions
- Signed informed consent before any study procedures
- Performance status of 2 or less on the ECOG scale
- Ability to swallow oral medications
- Adequate bone marrow and organ function based on laboratory tests
- Stable or decreasing corticosteroid dose for at least 5 days prior to first dose
- Negative pregnancy test or no longer of childbearing potential
- Use of effective contraception during and for 16 weeks after treatment (if applicable)
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Pregnancy or breastfeeding
- Known allergy to any component of BDTX-1535
- Active or uncontrolled severe infections or liver disease
- Active systemic bacterial, fungal, or viral infections requiring treatment
- Significant cardiovascular disease including recent heart failure, heart attack, unstable angina, arrhythmias, or stroke in past 6 months
- Symptomatic or radiographic leptomeningeal disease
- Serious uncontrolled preexisting medical conditions that may increase risk
- Use of prohibited medications such as strong CYP2C8, CYP3A4 inhibitors or inducers near study start
- Recent treatment with another investigational drug within 5 half-lives
- Unresolved toxicities from prior therapy greater than Grade 1, except alopecia, or chronic Grade 2 toxicities without investigator approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 5 days
Participants receive BDTX-1535 treatment once daily for 5 days prior to planned tumor resection to evaluate drug penetration in the central nervous system. Blood, tumor, and CSF samples will be collected during surgery.
1 to 2 visits including surgery day
Duration - 1 day
Participants undergo tumor resection surgery where samples are collected for drug concentration measurement.
1 surgical visit (in-person)
Duration - 28-day cycles continued until disease progression or other discontinuation
Participants with a pharmacokinetic or pharmacodynamic response continue BDTX-1535 treatment after surgery. Treatment may be given alone or combined with radiation therapy and/or temozolomide in 28-day cycles until disease progression, unacceptable toxicity, withdrawal, or study termination.
Continuous daily dosing with periodic visits as per standard of care
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
Research Team
P
Phase 0 Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here