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Latest
Clinical Trials in the EU / 2025-521180-13-00
Authorised, recruiting Phase I

PNOC023: Open Label Phase 1 and Target Validation Study of ONC206 in Children and Young Adults with Newly Diagnosed or Recurrent Diffuse Midline Glioma (DMG), and Other Recurrent Primary Malignant Central Nervous System (CNS) Tumors.

2025-521180-13-00 · tracked via the Priya Life Science EU tracker
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Neoplasms
Decision date
08/12/2025
Enrollment target
20
Sites
Netherlands

Condition studied

Diffuse Midline Glioma (DMG), and Other Recurrent Primary Malignant Central Nervous System (CNS) Tumors

Investigational medicinal product(s)

ONC206 Powder

Eligibility

Age group
0-17 years, 18-64 years
Sex
Female, Male

Primary endpoint

Dose escalation and expansion phase: MTD (Maximum tolerated dose); within the first 4 weeks of treatment for Arms A and D (without radiation) and the duration of radiation for Arms B and C (in combination with radiation), Target validation arms: Measurement for determining if the study drug passes the blood brain barrier and enters the tumor

Endpoint detail

Pharmacokinetic (PK) assessments for ONC206

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521180-13-00 on CTIS ↗ ← All trials in the EU