A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

October 18, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
High Grade GliomaGlioblastoma
Interventions
DRUG

BDTX-1535

BDTX-1535 is an inhibitor of EGFR mutations

DRUG

BDTX-1535 combined with radiation therapy

During Phase 1, BDTX-1535 concurrently with standard of care upfront RT, followed by adjuvant monotherapy with BDTX-1535 continuously in 28-day cycles after RT.

DRUG

BDTX-1535 combined with temozolomide and radiation therapy

During Phase 1, BDTX-1535 concurrently with standard of care upfront RT and TMZ, followed by adjuvant BDTX-1535 combined with standard of care TMZ continuously in 28-day cycles after RT.

Trial Locations (2)

85013

RECRUITING

St. Joseph's Hospital and Medical Center, Phoenix

85224

RECRUITING

Chandler Regional Medical Center, Chandler

All Listed Sponsors
collaborator

Ivy Brain Tumor Center

OTHER

collaborator

Barrow Neurological Institute

OTHER

lead

St. Joseph's Hospital and Medical Center, Phoenix

OTHER