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Monoclonal Antibodies
BDTX-1535 for Brain Tumor
Phase < 1
Recruiting
Led By Nader Sanai, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who have had a prior resection of diagnosed HGG (2021 WHO grade 3 and 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy.
Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
Must not have
Significant cardiovascular disease.
Symptomatic or radiographic leptomeningeal disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new drug to see if it can safely treat people with tumors reliant on a certain growth signal due to gene changes.
Who is the study for?
This trial is for patients with recurrent high-grade glioma brain tumors that have progressed after standard treatments, including surgery, temozolomide chemotherapy, and radiotherapy. Participants must have specific EGFR gene changes in their tumors and be able to swallow pills. They should be relatively stable physically (ECOG PS ≤2) and not have severe cardiovascular disease, active infections or liver disease.
What is being tested?
BDTX-1535 is being tested in this study. It's a new drug aimed at blocking a growth signal in cancers linked to certain EGFR protein alterations found only in the tumors. The goal is to see if it can safely help people whose tumors depend on this signal due to these genetic changes.
What are the potential side effects?
While the exact side effects of BDTX-1535 are not listed here, similar drugs often cause issues like fatigue, skin reactions, diarrhea, mouth sores and potential allergic reactions. Patients will be monitored closely for any adverse effects related to organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery for a high-grade glioma and have received standard treatments but my cancer has progressed.
Select...
I can perform all self-care but cannot work.
Select...
I can swallow pills.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious heart condition.
Select...
I have symptoms or imaging results showing disease in the lining of my brain or spinal cord.
Select...
I do not have any active infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS)
Total concentration of BDTX-1535 in tumor tissue
Unbound concentration of BDTX-1535 in tumor tissue
Secondary study objectives
Clinical laboratory abnormalities per CTCAE
Concentration of BDTX-1535 in CSF
Overall survival (OS)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Recurrent high-grade glioma participants with EGFR fusionExperimental Treatment1 Intervention
Group II: Recurrent high-grade glioma participants with EGFR alterationsExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
68 Previous Clinical Trials
17,340 Total Patients Enrolled
Ivy Brain Tumor CenterOTHER
11 Previous Clinical Trials
805 Total Patients Enrolled
Barrow Neurological InstituteOTHER
26 Previous Clinical Trials
7,001 Total Patients Enrolled
Nader Sanai, MDPrincipal InvestigatorChief Scientific Officer/Director of the Ivy Brain Tumor Center
13 Previous Clinical Trials
985 Total Patients Enrolled