Clinical Trial Finder

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.

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.

Arms

Interventions