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Study details
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ONC206 for Brain Tumors

Sabine Mueller, MD, PhD
NCT IDNCT04732065ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1

Target enrollment

208

Study length

about 5.9 years

Ages

2–21

Locations

4 sites in CA, GA, MI +1

What this study is about

This trial is testing ONC206, a new drug, alone or with radiation therapy, to treat brain tumors. The goal is to find the best dose of ONC206 and see if it can stop cancer cells from growing in patients with newly diagnosed or recurrent diffuse midline gliomas and other types of recurrent malignant CNS tumors.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Receive Standard of Care Radiation Therapy
  • 2.Take ONC206
  • 3.Undergo Optional Proton (1H) MR spectroscopy (MRS)

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Maximum tolerated dose (MTD) of ONC206, Proportion of participants with dose-limiting toxicities (DLT)

Secondary: Area under the curve (AUC) of ONC206, Elimination half-life (t1/2) of ONC206, Mean Total body clearance (CL) for ONC206, Mean corresponding time (Tmax) of ONC206, Mean maximum concentration (Cmax) of ONC206

Procedures

radiation

Body systems

Oncology