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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2029

Conditions
Neurofibromatosis Type IINF2
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.

All Listed Sponsors
lead

PRG Science & Technology Co., Ltd.

INDUSTRY

NCT07131722 - Study to Determine Optimal Dose, Evaluate the Efficacy and Safety of PRG-N-01 in Patients With Neurofibromatosis Type II | Biotech Hunter | Biotech Hunter