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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: 25 Aug 2024

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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

    • 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.
    • 13 Aug 2024 According to a Chimerix media release, Phase 1 dose escalation trial conducted in partnership with National Institutes of Health (NIH) has enrolled over 75 adult patients and dose escalation study has reached dose level 10 (of 11 planned levels) at 150mg twice per day for three consecutive days, with no dose limiting toxicity observed to date.
    • 01 Mar 2024 According to a Chimerix media release, the company is planning in completing enrolment in ONC206 dose escalation trial this year

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