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A Multi-center, Open-label, Single-arm Phase I Dose-escalation and Phase II Dose-expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1

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A Multi-center, Open-label, Single-arm Phase I Dose-escalation and Phase II Dose-expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Jun 2024

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At a glance

  • Drugs FCN 159 (Primary)
  • Indications Neurofibromatosis 1; Plexiform neurofibroma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Shanghai Fosun Pharmaceutical

    • Most Recent Events

    • 04 Jun 2024 Preliminary efficacy results (As of November 24, 2023, n=46 ) presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
    • 11 Sep 2023 Status changed from recruiting to active, no longer recruiting.
    • 06 Jun 2023 Results (at data cut-off: 21 November 2022; n=65) assessing safety and efficacy results in pediatric participants, presented at the 59th Annual Meeting of the American Society of Clinical Oncology.

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