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

NCT07131722 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-23

No results posted yet for this study

Summary

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

Conditions

  • Neurofibromatosis Type II
  • NF2

Interventions

DRUG

Trineumin

Trineumin(Code name: PRG-N-01) is administered orally once daily. The study includes six dose levels. Dose escalation decisions are based on observed DLTs.

DRUG

Trineumin

Trineumin(Code name: PRG-N-01) is administered orally once daily at the lower dose selected from Phase 1 results.

DRUG

Trineumin

Trineumin(Code name: PRG-N-01) is administered orally once daily at the higher dose selected from Phase 1 results.

Sponsors & Collaborators

  • PRG Science & Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131722 on ClinicalTrials.gov