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Clinical Trial Details — Status: Available

Administrative data

NCT number NCT05518838
Other study ID # OKN-007-EA-DMG
Secondary ID
Status Available
Phase
First received
Last updated

Study information

Verified date June 2024
Source Oblato, Inc.
Contact Shinwook Kang
Phone +1-609-734-4329
Email swkang@oblatoinc.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


Recruitment information / eligibility

Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 13 Months to 18 Years
Eligibility Inclusion Criteria: 1. Age from > 12 months to = 18 years of age at the time of enrollment. 2. 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. 3. Patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation. 4. 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. 5. Patients must have adequate bone marrow, liver, and renal function: 6. For females of childbearing potential, negative urinary or serum pregnancy test. 7. 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. 8. 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 9. 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. Exclusion Criteria: 1. 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. 2. 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. 3. Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation. 4. 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. 5. 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. 6. Known hypersensitivity to OKN-007 or any component in its formulation. 7. Patients taking prohibited medications as described in the current Investigator's Brochure. 8. Patient is pregnant or actively breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
OKN-007
OKN-007 is an intravenously administrated drug being developed as a novel anti-cancer therapy against gliomas.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Oblato, Inc.

Country where clinical trial is conducted

United States, 

See also
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Terminated NCT03330197 - A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG Phase 1/Phase 2
Terminated NCT03690869 - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma Phase 1/Phase 2
Active, not recruiting NCT02992015 - Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma Early Phase 1
Terminated NCT01182350 - Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) Phase 2
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Not yet recruiting NCT06093165 - RE-irradiation of Diffuse MIdline Glioma paTients N/A
Withdrawn NCT03632317 - A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas Phase 2
Completed NCT02502708 - Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors Phase 1
Recruiting NCT02233049 - Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication Phase 2
Completed NCT00996723 - Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) Phase 1
Recruiting NCT05009992 - Combination Therapy for the Treatment of Diffuse Midline Gliomas Phase 2
Recruiting NCT04049669 - Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG Phase 2