Phase 1 dose-escalation trial using convection-enhanced delivery of radio-immunotheranostic 124I-Omburtamab for diffuse intrinsic pontine glioma.

ABSTRACT:

Background

Median survival for patients with Diffuse Intrinsic Pontine Glioma (DIPG) is 8-12 months.

Methods

A phase 1, open label, 3 + 3 dose-escalation trial delivered radiolabeled 124I-Omburtamab, targeting B7-H3, using MR-guided stereotactic convection-enhanced delivery (CED) into the brainstem of pediatric DIPG patients. CED was performed after completion of standard-of-care external-beam radiation therapy (EBRT). Fifty children were treated and evaluable. 124I-Omburtamab activity was escalated from 0.25 to 10.0 mCi (9.25-370 MBq) and volume escalated from 0.25 mL to 10.0 mL with serial PET/MRI post administration. Safety was the primary outcome. National Cancer Institute Common Terminology Criteria for Adverse Events were assessed for 30 days following CED of 124I-Ombu

SUBMITTER: Souweidane MM 

PROVIDER: S-EPMC12448826 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature