MedTrace Logo

A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)

NCT04752813 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-26

No results posted yet for this study

Summary

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 RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma.

Conditions

Interventions

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 subcutaneously prior to the beginning of each week of BPM31510 therapy.

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 up to 12 cycles post BPM31510 treatment.

RADIATION

Radiation

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

Sponsors & Collaborators

  • BPGbio

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2026-08-25
Completion
2030-08-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04752813 on ClinicalTrials.gov