Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions

• Status: Recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Collaborators: Barrow Neurological Institute; Ivy Brain Tumor Center

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.