Purpose

This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of radiation therapy (RT) and concurrent temozolomide (TMZ) chemotherapy for patients with newly diagnosed glioblastoma (GB).

Category

IRB Number
STUDY00001094
NCT Number
NCT04752813
Sponsor
BPGbio -



Study Contact

Principal Investigator
Andrew Brenner

Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
18
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Patients with newly diagnosed pathologically verified GB (by the World Health Organization 2021 criteria or using molecular features defined in C-IMPACT, update 6) (26) with any evidence of residual disease (enhancing or fast fluid-attenuated inversion-recovery [FLAIR]).
    2. No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.

Exclusion Criteria

    History of clinically significant tumor-related cerebral hemorrhage.
    2. Patients with multicentric disease defined by tumors which have multiple discrete areas of contrast-enhancing tumor without connecting T2/FLAIR signal abnormality.
    3. Patients with diffuse leptomeningeal disease.
    4. Patients who are not eligible for definitive surgical resection.
    5. Patients on decadron daily dosing more than 2 mg.


Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Condition
  • Glioblastoma
  • Glioblastoma Multiforme

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    BPM31510, Vitamin K1, RT and TMZ

    		Subjects will receive a BPM31510 96hr infusion once weekly for 8 wk. Prophylactic Vitamin K1 at a recommended dose of 10 mg will be given intramuscular (IM) to all subjects prior to the beginning of each week of therapy. After 2 wk of treatment with BPM31510, subjects will start concurrent standard RT and TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for additional 6 cycles post BPM31510 treatment.
  • Drug: Temozolomide (TMZ)

    After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for additional 6 cycles post BPM31510 treatment.

  • Drug: BPM31510

    Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.

  • Other: Vitamin K1

    Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg Intramuscularly prior to the beginning of each week of BPM31510 therapy.

  • Radiation: Radiation

    After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.

    •