Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors

NCT04732065 · View on ClinicalTrials.gov ↗

Study Summary

This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.

Interventions

  • DRUG ONC206
  • RADIATION Standard of Care Radiation Therapy
  • PROCEDURE Optional Proton (1H) MR spectroscopy (MRS)

Study Locations (6)

California

  • University of California, San Francisco — San Francisco

Georgia

  • Emory University — Atlanta

Michigan

  • University of Michigan — Ann Arbor

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia

Other

  • Princess Máxima Center for Pediatric Oncology — Utrecht

Canton of Zurich

  • The University Children's Hospital in Zurich — Zurich

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2021-08-23
Est. Completion 2027-07-31
Phase Phase 1

Sponsor

Sabine Mueller, MD, PhD

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04732065

The ClinicalTrials.gov registry entry for NCT04732065 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sabine Mueller, MD, PhD, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions — of which ONC206 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04732065 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Georgia, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04732065 about?

NCT04732065 is a clinical study titled "ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors". This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compou...

What is the current status of trial NCT04732065?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 208 participants. The study started on 2021-08-23. Estimated completion is 2027-07-31.

What conditions does trial NCT04732065 study?

This clinical trial studies the following conditions: Glioblastoma, Recurrent Ependymoma, Central Nervous System Tumor, CNS Tumor, Diffuse Midline Glioma (DMG). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04732065?

The interventions under investigation include: ONC206 (DRUG), Standard of Care Radiation Therapy (RADIATION), Optional Proton (1H) MR spectroscopy (MRS) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04732065?

This trial is sponsored by Sabine Mueller, MD, PhD, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04732065 being conducted?

This trial has 6 study locations across California, Georgia, Michigan, Pennsylvania, Canton of Zurich. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial