Phase I Study of APX005M in Pediatric CNS Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- CNS Primary Tumor, Nos
- Diffuse Intrinsic Pontine Gliomas (DIPG)
- Ependymoma, NOS
- Glioblastoma Multiforme
- High-grade Astrocytoma NOS
- Medulloblastoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Stratum 1: Recurrent or refractory primary malignant CNS tumor patients; Stratum 2: Newly diagnosed DIPG patientsMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 21 years
- Gender
- Both males and females
Description
This is a multicenter phase I trial of APX005M in patients with recurrent or refractory primary malignant central nervous system tumor, or newly diagnosed diffuse intrinsic pontine glioma. APX005M is a humanized IgG1? mAb that binds to CD40. APX005M binds to both human and cynomolgus monkey CD40 wit...
This is a multicenter phase I trial of APX005M in patients with recurrent or refractory primary malignant central nervous system tumor, or newly diagnosed diffuse intrinsic pontine glioma. APX005M is a humanized IgG1? mAb that binds to CD40. APX005M binds to both human and cynomolgus monkey CD40 with high affinity, triggering activation of B cells, monocytes, and dendritic cells and stimulating cytokine release from both human and monkey lymphocytes and monocytes. APX005M does not bind to mouse or rat CD40. CD40 is also expressed on many human tumor cells, and APX005M can mediate a direct cytotoxic effect on CD40+ tumor cells. Activation of CD40 on tumor cells results in tumor cell apoptosis and inhibition of tumor growth. CD40 agonistic antibodies have demonstrated potent antitumor immune response stimulation in both animal models and cancer patients. Due to its action on both immune and tumor cells, CD40 has been studied as a target for novel cancer immunotherapy. Apexigen has declared the adult recommended phase 2 dose to be 0.3 mg/kg because no dose limiting toxicities were encountered at that dose and the pharmacodynamic profile was similar to the 1 mg/kg maximally tolerated dose. This phase 1 clinical trial is to study APX005M in children with central nervous system tumors.
Tracking Information
- NCT #
- NCT03389802
- Collaborators
- St. Jude Children's Research Hospital
- American Lebanese Syrian Associated Charities
- The Cancer Therapy Evaluation Program of the National Cancer Institute
- Apexigen, Inc.
- Solving Kids' Cancer
- Ty Louis Campbell Foundation
- A Kids' Brain Tumor Cure Foundation
- Investigators
- Study Chair: Ira Dunkel Memorial Sloan Kettering Cancer Center
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