A Phase I, Open-Label, Dose Escalation Study of Enoblituzumab in Children and Young Adults with B7-H3-Expressing Relapsed or Refractory Solid Tumors.

ABSTRACT:

Purpose

This multicenter, phase I, cohort expansion study was performed to characterize the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of enoblituzumab in children with relapsed/refractory tumors expressing B7-H3 above a predetermined threshold.

Patients and methods

Samples from 101 patients were screened for B7-H3 expression. Twenty-five patients with relapsed/refractory B7-H3-expressing solid tumors were enrolled in the trial with a median age of 14.8 years (range, 6-24 years). Enoblituzumab was administered intravenously weekly at 10 or 15 mg/kg.

Results

B7-H3 expression was documented in 96% of evaluable tumors by IHC. The maximum administered dose of enoblituzumab was the protocol-specified maximum dose of 15 mg

SUBMITTER: DeSantes KB 

PROVIDER: S-EPMC12421222 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature