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Monoclonal Antibodies

INCB7839 for Brain Cancer in Children

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
Off all colony-forming growth factors for at least 7 days
Failed at least 1 standard tumor-directed treatment besides surgery
Must not have
Significant family history of thrombosis in first-degree relatives
History of non-central line related thrombosis or clotting-promoting disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years following last dose of incb7839.
Awards & highlights
No Placebo-Only Group

Summary

This trial tests INCB7839, a drug that blocks proteins helping cancer cells grow, on children with tough-to-treat brain tumors that have returned or grown after initial treatment. The drug works by stopping a protein needed for tumor growth from being released.

Who is the study for?
This trial is for children aged 3-21 with recurrent or progressive high-grade brain tumors who can swallow pills. They must have measurable disease, be recovered from prior treatments, and have stable health conditions. Those with controlled seizures or neurological deficits may qualify. Patients on birth control and HIV-positive individuals under certain criteria are also eligible.
What is being tested?
The trial tests INCB7839 in children with high-grade gliomas that came back or got worse after initial treatment. It's a phase 1 study to see how safe the drug is and how it affects these types of brain tumors.
What are the potential side effects?
While specific side effects for INCB7839 aren't listed, common ones for cancer drugs include nausea, fatigue, blood count changes increasing infection risk, liver function issues, allergic reactions, and potential bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't taken any growth factor medications for over a week.
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I have tried at least one cancer treatment other than surgery and it didn't work.
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My neurological symptoms have not changed for at least a week.
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My brain tumor is aggressive and has come back or gotten worse.
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I am between 3 and 21 years old.
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My dose of dexamethasone has been stable or decreasing for the last week.
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My body surface area fits within the required range for my medication dose.
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I am between 3 and 21 years old.
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I can do most activities but may need assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My close family has a history of blood clots.
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I have had blood clots not related to a central line.
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I have not had significant new brain bleeding shown on an MRI in the last 2 weeks.
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I do not have any other type of cancer.
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I have a known bleeding or clotting disorder.
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I can attend all follow-up visits and stick to the study plan.
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My high blood pressure is not under control.
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I cannot receive blood clot prevention treatments.
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I am not on any other cancer treatments or experimental drugs.
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I use birth control that contains estrogen.
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I have had bleeding in my brain from a tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years following last dose of incb7839.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years following last dose of incb7839. 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 recommend Phase II dose (RP2D) of INCB7839.
To characterize the apparent oral clearance [CL/F] of INCB7839 administered on this schedule in children with recurrent/progressive high-grade glioma.
To characterize the area under the plasma concentration versus time curve (AUC) of INCB7839 administered on this schedule in children with recurrent/progressive high-grade glioma.
+3 more
Secondary study objectives
To make a preliminary assessment of duration of response in children with recurrent/progressive high-grade glioma.
To make a preliminary assessment of overall survival in children with recurrent/progressive high-grade glioma.
To make a preliminary assessment of progression-free survival in children with recurrent/progressive high-grade glioma.
Other study objectives
ADAM10 inhibition of HER2 extracellular domain in serum.
To assess and monitor ADAM10 inhibition of neuroligin-3 (NLGN3) in cerebral spinal fluid.
To characterize the maximum concentration [CMAX] of INCB7839 in cerebrospinal fluid.

Side effects data

From 2019 Phase 1 & 2 trial • 30 Patients • NCT02141451
50%
Lymphocyte count decreased
25%
Platelet count decreased
25%
Dysphagia
25%
Pain
25%
Anemia
25%
Nausea
25%
White blood cell decreased
25%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
INCB7839 200 mg (Phase I)
INCB7839 300 mg (Phase I)
INCB7839 300 mg (Phase II)
INCB7839 100 mg (Phase I)

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose-findingExperimental Treatment1 Intervention
INCB7839 dosing will begin at 120 mg/m2/dose BID which is equivalent to the adult RP2D (200 mg PO BID) based on a typical adult size of 1.67m2. The INCB7839 dose may be decreased to 80 mg/m2/dose BID if the staring dose is not tolerable. 28 consecutive days (4 weeks) will constitute one course. Patients may continue to receive INCB7839 for 26 courses (approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB7839
2014
Completed Phase 2
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy. Chemotherapy agents like temozolomide work by damaging the DNA of cancer cells, leading to cell death. Targeted therapies, such as INCB7839, inhibit metalloproteinases like ADAM10, which are involved in the shedding of cell surface proteins and may contribute to tumor progression and metastasis. These mechanisms are crucial for Glioblastoma patients as they aim to reduce tumor growth, prevent metastasis, and improve survival rates by targeting specific pathways involved in cancer cell proliferation and spread.

Find a Location

Who is running the clinical trial?

American Lebanese Syrian Associated Charities (ALSAC)UNKNOWN
8 Previous Clinical Trials
667 Total Patients Enrolled
4 Trials studying Glioblastoma
402 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,016,921 Total Patients Enrolled
330 Trials studying Glioblastoma
23,363 Patients Enrolled for Glioblastoma
American Lebanese Syrian Associated CharitiesOTHER
8 Previous Clinical Trials
667 Total Patients Enrolled
4 Trials studying Glioblastoma
402 Patients Enrolled for Glioblastoma

Media Library

INCB7839 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04295759 — Phase 1
Glioblastoma Research Study Groups: Dose-finding
Glioblastoma Clinical Trial 2023: INCB7839 Highlights & Side Effects. Trial Name: NCT04295759 — Phase 1
INCB7839 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04295759 — Phase 1
~2 spots leftby Nov 2025