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Trial Title:
Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions
NCT ID:
NCT06072586
Condition:
High Grade Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BDTX-1535
Description:
BDTX-1535 is an inhibitor of EGFR mutations
Arm group label:
Recurrent high-grade glioma participants with EGFR alterations
Arm group label:
Recurrent high-grade glioma participants with EGFR fusion
Summary:
This study will administer the investigational drug, BDTX-1535 to eligible patients with
recurrent high-grade glioma. 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.
Detailed description:
Eligible participants will enroll in the Phase 0 study and receive BDTX-1535 prior to a
planned resection. During surgery, blood, tumor, and CSF samples will be collected to
measure the amount of drug that is present in the samples. Participants with tumors
demonstrating PK response will continue with once-daily BDTX-1535 treatment, continuously
in 28-day cycles after surgery. Participants will continue to receive BDTX-1535 until the
progression of disease, unacceptable toxicity or death, withdrawal of consent, loss to
follow-up, or study termination by the sponsor.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- Adequate archival or biopsy tissue available for testing of EGFR alterations.
- Participants must have measurable disease preoperatively.
- Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group
(ECOG) scale.
- Ability to swallow oral medications.
- Participant has adequate bone marrow and organ function
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Known allergic reactions to components of the BDTX-1535.
- Known to have active (acute or chronic) or uncontrolled severe infection, liver
disease such as cirrhosis, decompensated liver disease, and active and chronic
hepatitis, as determined by the investigator.
- Known active systemic bacterial infection, fungal infection, or detectable viral
infection .
- Significant cardiovascular disease.
- Symptomatic or radiographic leptomeningeal disease.
- Participant has serious and/or uncontrolled preexisting medical condition(s) that,
in the judgment of the investigator, would preclude participation in this study .
- Concurrent use of prohibited medications.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Joseph's Hospital and Medical Center
Address:
City:
Phoenix
Zip:
85013
Country:
United States
Status:
Recruiting
Contact:
Last name:
Phase 0 Navigator
Phone:
602-406-8605
Email:
research@ivybraintumorcenter.org
Investigator:
Last name:
Nader Sanai, MD
Email:
Principal Investigator
Start date:
October 18, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
St. Joseph's Hospital and Medical Center, Phoenix
Agency class:
Other
Collaborator:
Agency:
Ivy Brain Tumor Center
Agency class:
Other
Collaborator:
Agency:
Barrow Neurological Institute
Agency class:
Other
Source:
St. Joseph's Hospital and Medical Center, Phoenix
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06072586
http://www.ivybraintumorcenter.org/
