CD40 Agonistic Monoclonal Antibody APX005M in Treating Pediatric Patients with Recurrent or Refractory Brain Tumors

Active:	No
Cancer Type:	Brain & Spinal Cord Tumor Unknown Primary	NCT ID:	NCT03389802
Trial Phases:	Phase I	Protocol IDs:	PBTC-051 (primary) PBTC-051 NCI-2017-01235
Eligibility:	1 - 21 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Pediatric Brain Tumor Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT03389802

Summary

This phase I trial studies the side effects and best dose of CD40 agonistic monoclonal antibody APX005M in treating pediatric patients with brain tumors that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with CD40 agonistic monoclonal antibody APX005M, may induce changes in the body’s immune system, and may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVES:
I. To evaluate the safety of CD40 agonistic monoclonal antibody APX005M (APX005M) administered intravenously every 3 weeks to children with central nervous system tumors.
II. To determine the maximum tolerated dose and/or the recommended phase II dose of APX005M.
III. To determine the pharmacokinetics of APX005M.

SECONDARY OBJECTIVE:
I. To make a preliminary assessment of efficacy via overall response rate, duration of response, progression-free survival and overall survival for diffuse intrinsic pontine glioma (DIPG) patients.

EXPLORATORY OBJECTIVES:
I. To assess the incidence of anti-drug antibodies.
II. To determine the immune pharmacodynamics of APX005M.
III. To identify tumor and blood efficacy and/or resistance biomarkers.

OUTLINE: This is a dose-escalation study.

Patients receive CD40 agonistic monoclonal antibody APX005M intravenously (IV) over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and magnetic resonance imaging (MRI) throughout the study.

After completion of study treatment, patients are followed up at 30 days, then up to 3 years.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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