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Monoclonal Antibodies

APX005M for Pediatric Brain Cancer

Phase 1
Waitlist Available
Research Sponsored by Pediatric Brain Tumor Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stratum 1: Patients with a histologically confirmed diagnosis of a primary malignant non-brainstem CNS tumor that is recurrent, progressive, or refractory
Patient must be ≥ 6 months since autologous bone marrow/stem cell transplant prior to enrollment and have CD4 counts above 200/mm3
Must not have
Patients with a history of severe (Grade ≥ 3) hypersensitivity reaction to a monoclonal antibody
Patients with any clinically significant unrelated systemic illness, serious infections Grade ≥ 2, or significant cardiac, pulmonary, hepatic or other organ dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor.

Who is the study for?
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.
What is being tested?
The trial tests APX005M's safety and optimal dosage in treating aggressive brain tumors in the young. It activates immune cells and may directly kill tumor cells expressing CD40. The study includes patients with new diagnoses of diffuse intrinsic pontine glioma (DIPG) as well as those with recurring or resistant CNS tumors.
What are the potential side effects?
Potential side effects of APX005M include reactions related to immune activation such as inflammation in various organs; it might also cause cytotoxic effects on certain tumor cells which could lead to a range of symptoms depending on the affected area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer in the central nervous system is returning, worsening, or not responding to treatment.
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It's been over 6 months since my stem cell transplant and my CD4 count is above 200.
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I am between 1 and 21 years old.
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My organs and bone marrow are functioning well.
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I can care for myself but may need occasional help.
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I had major surgery over 4 weeks ago and have recovered from it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a severe allergic reaction to a monoclonal antibody treatment.
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I do not have any serious illnesses or infections that could affect my participation.
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I have a bleeding disorder or need blood-thinning medication.
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I have an autoimmune disease that needs ongoing treatment with steroids or immunosuppressants.
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I am not currently on any cancer treatment or experimental drugs.
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I have received a stem cell transplant from a donor.
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I am not pregnant or breast-feeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 1
Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 2
Number of Patients Who Experienced Dose-limiting Toxicities (DLTs)
+1 more
Secondary study objectives
Duration of Response for Stratum 2 (DIPG) Patients
Overall Response Rate for Stratum 2 (DIPG) Patients
Overall Survival for Stratum 2 (DIPG) Patients
+1 more
Other study objectives
Concentration of the Cytokine Interleukin-8 (IL-8)
Concentration of the Cytokine Tumor Necrosis Factor-alpha (TNF-alpha)
Incidence of Anti-APX005M Antibodies
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stratum 2Experimental Treatment1 Intervention
The newly diagnosed diffuse intrinsic pontine gliomas (DIPGs) patients will be treated with APX005M.
Group II: Stratum 1Experimental Treatment1 Intervention
The recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients will be treated with APX005M.

Find a Location

Who is running the clinical trial?

American Lebanese Syrian Associated Charities (ALSAC)UNKNOWN
8 Previous Clinical Trials
653 Total Patients Enrolled
3 Trials studying Medulloblastoma
395 Patients Enrolled for Medulloblastoma
Pyxis Oncology, IncIndustry Sponsor
2 Previous Clinical Trials
140 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,112 Total Patients Enrolled
89 Trials studying Medulloblastoma
10,221 Patients Enrolled for Medulloblastoma

Media Library

APX005M (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03389802 — Phase 1
Medulloblastoma Research Study Groups: Stratum 1, Stratum 2
Medulloblastoma Clinical Trial 2023: APX005M Highlights & Side Effects. Trial Name: NCT03389802 — Phase 1
APX005M (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03389802 — Phase 1
~4 spots leftby Nov 2025
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