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RECRUITING Phase 2

Combination Therapy for the Treatment of Diffuse Midline Gliomas

NCT05009992 · View on ClinicalTrials.gov ↗

Study Summary

This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. This trial will utilize an adaptive platform design in that the different treatment arms for each cohort will be opened and closed based on ongoing preclinical investigation as well as evolving outcome data from the trial. Novel agents will be continuously added to this study as pre-clinical data emerge to suggest additive or synergistic activity when combined ONC201. Should a novel agent not have an RP2D at the time of incorporation into this study, a phase 1 lead-in will be performed prior to initiation of combination therapy (via study amendment).

Interventions

  • RADIATION Radiation Therapy
  • DRUG Paxalisib
  • DRUG ONC201
  • DRUG DNX-2401

Study Locations (20)

California

  • Children's Hospital Los Angeles — Los Angeles
  • University of California, San Diego / Rady Children's Hospital, San Diego — San Diego
  • University of California, San Francisco — San Francisco

Alabama

  • University of Alabama at Birmingham — Birmingham

District of Columbia

  • Children's National Hospital — Washington D.C.

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago

Indiana

  • Indiana University Riley Children's Hospital — Indianapolis

Maryland

  • Johns Hopkins University — Baltimore

Massachusetts

  • Dana-Farber Cancer Institute Harvard University — Boston

Michigan

  • University of Michigan — Ann Arbor

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2021-10-20
Est. Completion 2029-06-30
Phase Phase 2

Sponsor

University of California, San Francis

1,574 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05009992

The ClinicalTrials.gov registry entry for NCT05009992 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Diffuse Intrinsic Pontine Glioma appearing as the primary indexed condition, and to 4 interventions — of which Radiation Therapy 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: NCT05009992 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Alabama, District of Columbia. 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 NCT05009992 about?

NCT05009992 is a clinical study titled "Combination Therapy for the Treatment of Diffuse Midline Gliomas". This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment opti...

What is the current status of trial NCT05009992?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2021-10-20. Estimated completion is 2029-06-30.

What conditions does trial NCT05009992 study?

This clinical trial studies the following conditions: Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, WHO Grade III Glioma, Recurrent WHO Grade III Glioma, Recurrent Diffuse Intrinsic Pontine Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05009992?

The interventions under investigation include: Radiation Therapy (RADIATION), Paxalisib (DRUG), ONC201 (DRUG), DNX-2401 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05009992?

This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05009992 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Illinois, Indiana. 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