Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
1 other identifier
expanded_access
N/A
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedNovember 8, 2024
November 1, 2024
August 24, 2022
November 6, 2024
Conditions
Interventions
OKN-007 is an intravenously administrated drug being developed as a novel anti-cancer therapy against gliomas.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oblato, Inc.lead
Study Sites (9)
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Hospital and Medical Center
Omaha, Nebraska, 68114, United States
Prisma Health Midlands Pediatric Hematology/Oncology
Columbia, South Carolina, 29203, United States
Children's Health
Dallas, Texas, 75235, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 29, 2022
Last Updated
November 8, 2024
Record last verified: 2024-11