Testing INCB007839 in Patients with Recurrent, Progressive High-Grade Glioma

Active:	No
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT04295759
Trial Phases:	Phase I	Protocol IDs:	PBTC-056 (primary) PBTC-056 NCI-2019-08964
Eligibility:	3 - 21 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Pediatric Brain Tumor Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT04295759

Summary

This phase I trial studies the side effects and best dose of aderbasib (INCB007839) in treating patients with high-grade glioma that has come back (recurrent) or that is growing, spreading, or getting worse (progressive). Aderbasib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of INCB007839 in children with recurrent/progressive high-grade gliomas, including diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), glioblastoma (GBM) and anaplastic astrocytoma.
II. To estimate the maximum tolerated dose (MTD) and/or recommend phase II dose (RP2D) of INCB007839 administered orally in children with recurrent/progressive high-grade glioma.
III. To characterize the plasma pharmacokinetics of INCB007839 administered on this schedule in children with recurrent/progressive high-grade glioma.

SECONDARY OBJECTIVE:
I. To make a preliminary assessment of efficacy via objective response and overall survival in children with recurrent/progressive high-grade glioma.

EXPLORATORY OBJECTIVES:
I. To assess and monitor ADAM10 inhibition of HER2 (human epidermal growth factor receptor 2) extracellular domain in serum, and explore potential correlation with patient outcome.
II. To assess and monitor ADAM10 inhibition of neuroligin-3 (NLGN3) in cerebral spinal fluid.
III. To characterize the pharmacokinetics of INCB007839 in cerebrospinal fluid.

OUTLINE:
Patients receive aderbasib orally (PO) twice daily (BID) on day 1-28. Patients also undergo magnetic resonance imaging (MRI) and X-ray imaging on study. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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