Phase I trial and pharmacokinetic study of lexatumumab in pediatric patients with solid tumors.

ABSTRACT:

Purpose

Lexatumumab is an agonistic, fully human monoclonal antibody against tumor necrosis factor-related apoptosis-inducing ligand receptor 2 with preclinical evidence of activity in pediatric solid tumors.

Patients and methods

This phase I dose-escalation study examined the safety, tolerability, pharmacokinetics, and immunogenicity of lexatumumab at doses up to, but not exceeding, the adult maximum-tolerated dose (3, 5, 8, and 10 mg/kg), administered once every 2 weeks to patients age≤21 years with recurrent or progressive solid tumors.

Results

Twenty-four patients received a total of 56 cycles of lexatumumab over all four planned dose levels. One patient had grade 2 pericarditis consistent with radiation recall, and one patient developed grade 3 pneumonia with hyp

SUBMITTER: Merchant MS 

PROVIDER: S-EPMC3494837 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature