APX005M for Pediatric Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does exclude patients who are on certain anticancer or investigational drugs, and those requiring systemic corticosteroids or immunosuppressive medications within 14 days of the study drug. It's best to discuss your specific medications with the trial team.
How does the drug APX005M differ from other treatments for pediatric brain cancer?
APX005M is unique because it targets specific molecular alterations in pediatric brain tumors, such as the BRAF pathway, which is involved in cell growth and survival. This targeted approach may offer a more precise treatment option compared to traditional chemotherapy and radiation, which are less specific and can have more side effects.12345
Who Is on the Research Team?
Ira Dunkel
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for children and young adults aged 1 to 21 with primary malignant non-brainstem CNS tumors that are recurrent, progressive, or refractory, or those newly diagnosed with DIPG. Participants must have stable neurological deficits, adequate organ function, not be pregnant or breastfeeding, use effective contraception methods if applicable, and meet specific recovery criteria from previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive APX005M to determine the safety, tolerability, and optimal dosing in pediatric patients with CNS tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- APX005M
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pediatric Brain Tumor Consortium
Lead Sponsor
American Lebanese Syrian Associated Charities (ALSAC)
Collaborator
Pyxis Oncology, Inc
Industry Sponsor
National Cancer Institute (NCI)
Collaborator
Apexigen America, Inc.
Industry Sponsor
American Lebanese Syrian Associated Charities
Collaborator
Ty Louis Campbell Foundation
Collaborator
A Kids' Brain Tumor Cure Foundation
Collaborator
Apexigen, Inc.
Industry Sponsor
Solving Kids' Cancer
Collaborator