Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered

NO_LONGER_AVAILABLE

Conditions studied: Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma

In brief

To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol.

Key facts

Study ID

NCT05518838

Run by

Oblato, Inc.

Last updated by the study team

2024-11-08

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age from > 12 months to ≤ 18 years of age at the time of enrollment.
• Diagnosis of diffuse midline glioma, H3 K27-altered according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
• Patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation.
• Karnofsky performance status ≥ 50 for patients ≥ 16 years of age and Lansky performance status ≥ 50 for patients < 16 years of age; patients who are unable to walk because of paralysis, but who are upright in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Patients must have adequate bone marrow, liver, and renal function:
• For females of childbearing potential, negative urinary or serum pregnancy test.
• Patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration.
• Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant
• Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.

You may not qualify if…

• Patient is already participating in or qualifies for and is able to enroll in a clinical trial of OKN-007 and other ongoing clinical trials.
• Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting OKN-007 treatment, whichever is shorter.
• Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.
• Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with OKN-007 due to safety concerns.
• Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with OKN-007.
• Known hypersensitivity to OKN-007 or any component in its formulation.
• Patients taking prohibited medications as described in the current Investigator's Brochure.
• Patient is pregnant or actively breastfeeding.

Where it is running

• Arkansas Children's Research Institute — Little Rock, Arkansas, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Children's Hospital and Medical Center — Omaha, Nebraska, United States
• Prisma Health Midlands Pediatric Hematology/Oncology — Columbia, South Carolina, United States
• Children's Health — Dallas, Texas, United States
• Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
• Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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