Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions
- Conditions
- High Grade Glioma
- Registration Number
- NCT06072586
- Lead Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria:<br><br> - Participants who have had a prior resection of diagnosed HGG (2021 WHO grade 3 and<br> 4), defined as participants who have progressed on or following standard therapy,<br> which includes maximal surgical resection, temozolomide, and fractionated<br> radiotherapy.<br><br> - Adequate archival or biopsy tissue available for testing of EGFR alterations.<br><br> - Participants must have measurable disease preoperatively.<br><br> - Have a performance status (PS) of =2 on the Eastern Cooperative Oncology Group<br> (ECOG) scale.<br><br> - Ability to swallow oral medications.<br><br> - Participant has adequate bone marrow and organ function<br><br>Exclusion Criteria:<br><br> - Pregnancy or breastfeeding.<br><br> - Known allergic reactions to components of the BDTX-1535.<br><br> - Known to have active (acute or chronic) or uncontrolled severe infection, liver<br> disease such as cirrhosis, decompensated liver disease, and active and chronic<br> hepatitis, as determined by the investigator.<br><br> - Known active systemic bacterial infection, fungal infection, or detectable viral<br> infection .<br><br> - Significant cardiovascular disease.<br><br> - Symptomatic or radiographic leptomeningeal disease.<br><br> - Participant has serious and/or uncontrolled preexisting medical condition(s) that,<br> in the judgment of the investigator, would preclude participation in this study .<br><br> - Concurrent use of prohibited medications.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Unbound concentration of BDTX-1535 in tumor tissue;Total concentration of BDTX-1535 in tumor tissue;Progression Free Survival (PFS)
- Secondary Outcome Measures
Name Time Method Concentration of BDTX-1535 in CSF;Percentage of pEGFR positive cells in tumor tissue;Percentage of pERK positive cells in tumor tissue;Overall survival (OS);Safety and tolerability - adverse events;Safety and tolerability - death;Clinical laboratory abnormalities per CTCAE