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PBTC-051: Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma

Primary Objective

1.1 Primary Objectives 1.1.1 To evaluate the safety of APX005M administered intravenously every 3 weeks to children with central nervous system tumors. 1.1.2 To determine the maximum tolerated dose and/or the recommended phase II dose of APX005M. 1.1.3 To determine the pharmacokinetics of APX005M. 1.2 Secondary Objective 1.2.1 To make a preliminary assessment of efficacy via overall response rate, duration of response, progression-free survival and overall survival for DIPG patients. 1.3 Exploratory Objectives 1.3.1 To assess the incidence of anti-drug antibodies. 1.3.2 To determine the immune pharmacodynamics of APX005M. 1.3.3 To identify tumor and blood efficacy and/or resistance biomarkers.

Study category: Cancer

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Details
Age

Child to Adult

Phase

I - Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants.

Type of Study

Treatment

Location

Childrens Hospital Colorado

Principal Investigator
Kathleen Dorris,  MD

Kathleen Dorris, MD

Study ID

Protocol Number: 17-2394

ClinicalTrials.gov: NCT03389802

Categories

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