drugset / Trial / NCT03389802
Phase I Study of APX005M in Pediatric Central Nervous System Tumors
Phase 1
Active not recruiting
32 enrolled
Pediatric Brain Tumor Consortium
A Kids' Brain Tumor Cure Foundation · collabAmerican Lebanese Syrian Associated Charities · collabNational Cancer Institute (NCI) · collabPyxis Oncology · collabSolving Kids' Cancer · collabTy Louis Campbell Foundation · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2018-03-01
- Primary completion
- 2023-09-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sotigalimab | Monoclonal antibody | 0.03 mg/kg | — |
| Subject | sotigalimab | Monoclonal antibody | 0.1 mg/kg | — |
| Subject | sotigalimab | Monoclonal antibody | 0.3 mg/kg | — |
| Subject | sotigalimab | Monoclonal antibody | 0.45 mg/kg | — |
| Subject | sotigalimab | Monoclonal antibody | 0.6 mg/kg | — |