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Study identifier: NCT05009992 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Combination Therapy for the Treatment of Diffuse Midline Gliomas

Condition: Diffuse Intrinsic Pontine Glioma · Diffuse Midline Glioma, H3 K27M-Mutant · Recurrent Diffuse Intrinsic Pontine Glioma  ·  Sponsor: University of California, San Francisco

PhasePhase 2
Planned participants360
Who can joinAll sexes, 2 Years to 39 Years
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Kelly Hitchner  ·  (415) 502-1600  ·  PNOC022@ucsf.edu

Always discuss trial participation with your own doctor first.

Locations (32)

University of Alabama at BirminghamBirmingham, Alabama, United StatesRecruiting
Children's Hospital Los AngelesLos Angeles, California, United StatesRecruiting
University of California, San Diego / Rady Children's Hospital, San DiegoSan Diego, California, United StatesRecruiting
University of California, San FranciscoSan Francisco, California, United StatesRecruiting
Children's National HospitalWashington D.C., District of Columbia, United StatesRecruiting
Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois, United StatesRecruiting
Indiana University Riley Children's HospitalIndianapolis, Indiana, United StatesRecruiting
Johns Hopkins UniversityBaltimore, Maryland, United StatesRecruiting
Dana-Farber Cancer Institute Harvard UniversityBoston, Massachusetts, United StatesRecruiting
University of MichiganAnn Arbor, Michigan, United StatesRecruiting
Children's Hospital MinnesotaMinneapolis, Minnesota, United StatesRecruiting
Washington University in St. LouisSt Louis, Missouri, United StatesRecruiting

+ 20 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05009992