Childrens National Medical Center(5.3 mi away)Contact
+10 other location
germ cell tumor
diffuse intrinsic pontine glioma
central nervous system tumor
hematopoietic stem cell transplantation
malignant central nervous system tumor
mri of spine
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 stimulat cytokine release
from lymphocytes and monocytes. APX005M can mediate a direct cytotoxic effect on CD40+ tumor
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
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.
APX005M treatment for recurrent or refractory primary malignant CNS tumor patients,
APX005M treatment for newly diagnosed DIPG patients
Clinical Study Identifier
Pediatric Brain Tumor Consortium
Last Modified on
28 September 2020
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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