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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: 10 Feb 2025

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At a glance

  • Drugs ONC-206 (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 Chimerix; Oncoceutics

Most Recent Events

  • 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.
  • 13 Aug 2024 According to a Chimerix media release, company expects to assess any objective responses in the first half of 2025, allowing sufficient time for response onset and confirmation in current and future dose cohorts. Completion of enrollment in remaining two planned dose escalation cohorts is expected to occur in 2024.

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