Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 courses (approximately 2 years)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cancer in the central nervous system is returning, worsening, or not responding to treatment.
Select...
It's been over 6 months since my stem cell transplant and my CD4 count is above 200.
Select...
I am between 1 and 21 years old.
Select...
My organs and bone marrow are functioning well.
Select...
I can care for myself but may need occasional help.
Select...
I had major surgery over 4 weeks ago and have recovered from it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 courses (approximately 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 courses (approximately 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 Stratum 1 patients who experienced dose-limiting toxicities (DLTs)
+2 moreSecondary outcome measures
Duration of response for Stratum 2 patients
Overall response rate for Stratum 2 patients
Overall survival for Stratum 2 patients
+1 moreOther outcome measures
T cell phenotypes in human PBMC
The RNAseq of tumor tissue and PBMC
The TCR sequencing of tumor tissue and PBMC
+3 moreTrial 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
4 Trials studying Astrocytoma
388 Patients Enrolled for Astrocytoma
Pyxis Oncology, IncIndustry Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,332 Total Patients Enrolled
140 Trials studying Astrocytoma
13,570 Patients Enrolled for Astrocytoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a newly diagnosed brainstem tumor without needing a biopsy.I have had a severe allergic reaction to a monoclonal antibody treatment.My cancer in the central nervous system is returning, worsening, or not responding to treatment.I have recovered from side effects of my previous cancer treatments.My neurological symptoms have been stable for at least a week.I do not have any serious illnesses or infections that could affect my participation.I've been cancer-free for 5 years, except for a secondary brain tumor.I have a bleeding disorder or need blood-thinning medication.It's been over 6 months since my stem cell transplant and my CD4 count is above 200.I am between 1 and 21 years old.I received my last cancer treatment affecting my bone marrow 21 days ago, or 42 days ago if it was a specific type called nitrosourea.I have an autoimmune disease that needs ongoing treatment with steroids or immunosuppressants.I am not currently on any cancer treatment or experimental drugs.I have received a stem cell transplant from a donor.I am a woman who can have children and have a negative pregnancy test.My organs and bone marrow are functioning well.I am not pregnant or breast-feeding.I had significant radiation therapy more than 3 months ago.I am of any gender and ethnicity.I can care for myself but may need occasional help.You have a large tumor seen on imaging.I will use birth control or abstain from sex while on APX005M and for 30 days after.I had major surgery over 4 weeks ago and have recovered from it.I've recovered from side effects of my last biological treatment, which was over a week ago.Enough time has passed since my last monoclonal antibody treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum 1
- Group 2: Stratum 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger