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Study to Determine Optimal Dose, Evaluate the Efficacy and Safety of PRG-N-01 in Patients With Neurofibromatosis Type II

StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Nov 2027 to Jul 2028
    • Start date: Oct 2025 to Jul 2026
    • Study completion date: Nov 2029 to Jul 2028
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if Trineumin(Code name:PRG-N-01) works to treat Neurofibromatosis Type II(NF2) in adults. It will also learn about the safety and tolerability and toxicity of PRG-N-01. The main questions it aims to answer are: * What dose was determined as the Maximum Tolerated Dose (MTD) of Trineumin? * What dose was explored as the optimal effective dose of Trineumin based on radiographic response? * Does Trineumin reduce tumor size or improve participants' quality of life, including hearing function? * What medical problems do participants have when taking Trineumin? Participants will: * Take Trineumin every day for 96 weeks * Visit the clinic once 1, 4, 8, 12, 18week and every 12 weeks and for checkups and tests
Trial Details
NCT Number NCT07131722
Lead Sponsor PRG Science & Technology Co., Ltd.
Conditions
(from sponsor)		 Neurofibromatosis Type II, NF2
Related terms Neurofibromatosis 2
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov