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Phase I Study of APX005M in Pediatric Central Nervous System Tumors
NCT03389802 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL APX005M treatment for recurrent or refractory primary malignant CNS tumor patients
- BIOLOGICAL APX005M treatment for newly diagnosed DIPG patients
Study Locations (11)
California
- Children's Hospital Los Angeles — Los Angeles
- Lucile Packard Children Hospital Stanford University — Palo Alto
Colorado
- Children's Hospital Colorado — Aurora
District of Columbia
- Childrens National Medical Center — Washington D.C.
Georgia
- Children's Healthcare of Atlanta — Atlanta
Illinois
- Lurie Childrens Hospital-Chicago — Chicago
New York
- Memorial Sloan Kettering Cancer Center — New York
Ohio
- Cincinnati Children Hospital Medical Center — Cincinnati
Pennsylvania
- Children Hospital of Pittsburgh of UPMC — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03389802
The ClinicalTrials.gov registry entry for NCT03389802 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pediatric Brain Tumor Consortium, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions — of which APX005M treatment for recurrent or refractory primary malignant CNS tumor patients is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03389802 reports 11 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03389802 about?
NCT03389802 is a clinical study titled "Phase I Study of APX005M in Pediatric Central Nervous System Tumors". 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 c...
What is the current status of trial NCT03389802?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-03-01. Estimated completion is 2026-06-30.
What conditions does trial NCT03389802 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Medulloblastoma, Diffuse Intrinsic Pontine Gliomas (DIPG), High-grade Astrocytoma Not Otherwise Specified (NOS), CNS Primary Tumor, Not Otherwise Specified (NOS). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03389802?
The interventions under investigation include: APX005M treatment for recurrent or refractory primary malignant CNS tumor patients (BIOLOGICAL), APX005M treatment for newly diagnosed DIPG patients (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03389802?
This trial is sponsored by Pediatric Brain Tumor Consortium, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03389802 being conducted?
This trial has 11 study locations across California, Colorado, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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