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Stress Response Inducer

ONC206 + Radiation Therapy for Brain Tumor (PNOC023 Trial)

Phase 1
Recruiting
Research Sponsored by Sabine Mueller, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
TARGET VALIDATION: Children and young adults with recurrent primary malignant CNS tumors, including recurrent DMG, who have evidence of progression but have not been treated for this progression
Serum creatinine < 1.5 Upper Limit normal (ULN) based on age and gender
Must not have
Participants with a known disorder that affects their immune system, such as HIV, hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy
Participants with uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total)
Awards & highlights

Summary

This trial studies the effects of ONC206, a new drug that stresses out cancer cells to kill them, in children and young adults with difficult-to-treat brain tumors. The drug can be used alone or with radiation therapy. ONC206 is related to ONC201, which has shown promise in treating certain types of brain tumors.

Who is the study for?
This trial is for children and adults with newly diagnosed or recurrent diffuse midline gliomas (DMG) and other malignant CNS tumors. Participants must have stable vital signs, not be pregnant or breastfeeding, agree to use contraception if applicable, and cannot be on certain medications that affect ONC206 absorption or immune system disorders.
What is being tested?
The trial is testing the effectiveness of a new drug called ONC206 alone or combined with standard radiation therapy. The goal is to find the best dose that can stop tumor growth by triggering a stress response in cancer cells without harming normal cells.
What are the potential side effects?
Potential side effects of ONC206 are not detailed here but may include reactions related to the body's stress response to treatment. Standard radiation therapy side effects typically include fatigue, skin irritation at the treatment site, and potential hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child has a recurring brain tumor that has progressed but hasn't been treated for this progression.
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My kidney function, measured by creatinine, is within the normal range for my age and gender.
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I am newly diagnosed with a specific brain tumor showing certain genetic changes.
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I am willing to provide tissue samples for the study.
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My previous tests confirmed I have a malignant brain tumor.
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My tumor is confirmed as DMG, H3K27 altered by a pathology test.
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My tumor is confirmed to have a specific genetic change known as DMG, H3K27 altered.
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I am a young person newly diagnosed with a specific brain or spinal tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an immune system disorder like HIV, hepatitis B or C, or an autoimmune disease.
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I do not have any infections that are currently uncontrolled.
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I haven't taken strong enzyme affecting drugs for 14 days and won't during the study.
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I am pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total) 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) of ONC206
Proportion of participants with dose-limiting toxicities (DLT)
Secondary study objectives
Area under the curve (AUC) of ONC206
Elimination half-life (t1/2) of ONC206
Mean Total body clearance (CL) for ONC206
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D: ONC206 Therapy, Primary malignant CNS tumors with progressionExperimental Treatment2 Interventions
Patients receive ONC206 PO once a day (QD) up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm C: ONC206 + radiation therapy, DMGs with evidence of first progression but previously untreatedExperimental Treatment3 Interventions
Patients undergo standard of care radiation therapy daily 5 days a week and receive ONC206 PO up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Group III: Arm B: ONC206 + radiation therapy for newly diagnosed participantsExperimental Treatment3 Interventions
Patients undergo standard of care radiation therapy daily 5 days a week and receive ONC206 PO up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Group IV: Arm A: ONC206 for participants with diffuse midline gliomas + prior therapyExperimental Treatment2 Interventions
Patients receive ONC206 orally (PO) up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

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 Diffuse Midline Glioma include radiation therapy and emerging targeted therapies like ONC206. Radiation therapy works by damaging the DNA of cancer cells, leading to cell death and slowing tumor growth. ONC206, a novel compound, induces a stress response in tumor cells, causing them to die without affecting normal cells. This mechanism is crucial for Diffuse Midline Glioma patients as it offers a targeted approach that minimizes damage to healthy brain tissue, potentially improving outcomes and reducing side effects compared to traditional therapies.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,103 Previous Clinical Trials
359,224 Total Patients Enrolled
The ChadTough Defeat DIPG FoundationUNKNOWN
Storm the Heavens FundUNKNOWN
1 Previous Clinical Trials
360 Total Patients Enrolled

Media Library

ONC206 (Stress Response Inducer) Clinical Trial Eligibility Overview. Trial Name: NCT04732065 — Phase 1
Diffuse Midline Glioma Research Study Groups: Arm D: ONC206 Therapy, Primary malignant CNS tumors with progression, Arm B: ONC206 + radiation therapy for newly diagnosed participants, Arm A: ONC206 for participants with diffuse midline gliomas + prior therapy, Arm C: ONC206 + radiation therapy, DMGs with evidence of first progression but previously untreated
Diffuse Midline Glioma Clinical Trial 2023: ONC206 Highlights & Side Effects. Trial Name: NCT04732065 — Phase 1
ONC206 (Stress Response Inducer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732065 — Phase 1
~93 spots leftby May 2027