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A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

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Trial Profile

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Jan 2026

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At a glance

  • Drugs JZP 3507 (Primary)
  • Indications Anaplastic astrocytoma; Astrocytoma; CNS cancer; Ependymoma; Glioblastoma; Glioma; Gliosarcoma; Medulloblastoma; Meningioma; Neuroectodermal tumours; Neuroepithelial neoplasms; Oligodendroglioma; Primitive neuroectodermal tumours; Sarcoma; Tumours
  • Focus Adverse reactions; First in man
  • Sponsors Jazz Pharmaceuticals Inc

Most Recent Events

  • 17 Dec 2025 Planned primary completion date changed from 1 Dec 2025 to 1 Jul 2026.
  • 07 Feb 2025 Planned End Date changed from 1 Feb 2025 to 1 Dec 2026.
  • 07 Feb 2025 Planned primary completion date changed from 1 Sep 2024 to 1 Dec 2025.

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