NCT04771897 - A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 24, 2021

Primary Completion Date

October 4, 2024

Study Completion Date

October 4, 2024

Conditions

Diffuse Intrinsic Pontine GliomaDiffuse Midline Glioma, H3 K27M-Mutant

Interventions

DRUG

BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance

BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). During Part 1, BXQ-350 will be administered by intravenous (IV) infusion over twelve months.

DRUG

BXQ-350 - Part 2 BXQ-350 Tumor and Plasma Concentrations

BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). During Part 2, BXQ-350 will be administered by intravenous (IV) infusion over twelve months.

Trial Locations (3)

43205

Nationwide Children's, Columbus

45226

Cincinnati Children's Hospital Medical Center, Cincinnati

80045

Children's Hospital Colorado, Aurora