Phase I Study of APX005M in Pediatric Central Nervous System Tumors
Public ClinicalTrials.gov record NCT03389802. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. APX005M can trigger activation of B cells, monocytes, and dendritic cells and stimulate cytokine release from lymphocytes and monocytes. APX005M can mediate a direct cytotoxic effect on CD40+ tumor cells.
Study identification
- NCT ID
- NCT03389802
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Interventions
- APX005M treatment for recurrent or refractory primary malignant CNS tumor patients Biological
- APX005M treatment for newly diagnosed DIPG patients Biological
Biological
Eligibility (public fields only)
- Age range
- 1 Year to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2018
- Primary completion
- Sep 29, 2023
- Completion
- Jul 19, 2026
- Last update posted
- Aug 12, 2026
2018 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90026 | — |
| Lucile Packard Children Hospital Stanford University | Palo Alto | California | 94304 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Childrens National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Lurie Childrens Hospital-Chicago | Chicago | Illinois | 60614 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Cincinnati Children Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Children Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| St. Jude Children Research Hospital | Memphis | Tennessee | 38105 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03389802, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03389802 live on ClinicalTrials.gov.