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.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521180-13-00

Acronym

PNOC023

Enrollment

Registered

2025-12-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

Pharmacokinetic (PK) assessments for ONC206

Interventions

DRUGONC206 Powder

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
Pharmacokinetic (PK) assessments for ONC206	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026