NCT06739213

A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma

SYHA1813 vs Investigators' Choice as Treatment for Recurrent or Progressive High-Grade Meningioma: A Randomized, Controlled, Multicenter, Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, open-label, multicenter, Phase II clinical study designed to evaluate the efficacy and safety of SYHA1813 compared to investigators' choice in participants with recurrent or progressive high-grade meningioma.

Detailed description

A total of 56 participants with recurrent or progressive high-grade meningioma who are not eligible for local therapy will be enrolled. Participants will be randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group). The primary endpoint is the 6-month progression-free survival (PFS) rate assessed by investigators using the Response Assessment in Neuro-Oncology Working Group（ RANO criteria） for meningioma.

Conditions

• Recurrent or Progressive High Grade Meningioma

Interventions

Type	Name	Description
DRUG	SYHA1813	The starting dose of SYHA1813 is 20mg QD
DRUG	Investigator's Choice Treatment	Investigator's Choice Treatment

Timeline

• Start date: 2025-01-31
• Primary completion: 2027-01-31
• Completion: 2028-01-13
• First posted: 2024-12-18
• Last updated: 2024-12-18