A Phase III Study of SYHA1813 for Recurrent or Progressive High-Grade Meningiomas

NCT07613450 | Not Yet Recruiting Phase 3

• 1 other identifier: SYHA1814-006
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, controlled, open-label, multicenter, Phase III clinical study designed to compare the efficacy and safety of SYHA1813 versus treatment of investigators' choice in patients with recurrent or progressive high-grade meningioma not amenable to local therapy.

Conditions

High Grade Meningioma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) as Assessed by RANO Criteria and Evaluated by BIRC

  Up to approximately 4 years

Secondary Outcomes (12)

• PFS as Assessed by RANO Criteria and Evaluated by investigators

  Up to approximately 4 years

• Overall Survival (OS)

  Up to approximately 4 years

• Overall Survival Rate at 12 Months (OS-12)

  Up to approximately 4 years

• Progression Free Survival Rate at 6 Months (PFS-6) as Assessed by RANO Criteria

  Up to approximately 4 years

• Objective Response Rate (ORR) as Assessed by RANO Criteria

  Up to approximately 4 years

Study Arms (2)

Experimental group

EXPERIMENTAL

SYHA1813

Drug: SYHA1813

Control group

ACTIVE COMPARATOR

Investigator's Choice Treatment

Drug: Investigator's Choice Treatment

Interventions

SYHA1813 DRUG

SYHA1813 20mg QD

Experimental group

Investigator's Choice Treatment DRUG

Investigator's Choice Treatment：bevacizumab, temozolomide or hydroxyurea

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged \>= 18 years.
• \. Histologically confirmed WHO grade II/III meningioma (WHO CNS 5th) that is progressive or recurrent.
• \. Individuals must have received surgery and radiation therapy.
• \. There is at least one measurable intracranial tumor lesion in the baseline period (RANO-meningioma).
• \. KPS≥60.
• \. The expected survival time is \>=3 months.
• \. The organ function level and related laboratory indicators must meet requirement.
• \. Agree to use reliable and effective methods of contraception during the study treatment period and for at least 3 months after the last study treatment.

You may not qualify if:

• \. Individuals who are known to have severe allergic reaction to the study drug or any other ingredients/excipients in the formulation.
• \. Meets one of the following conditions: patients with brainstem involvement or extracranial metastasis; patients with severe brain herniation or at risk of brain herniation.
• \. History of other malignant tumors within 3 years or concurrent active malignant tumors.
• \. The toxic reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade 1.
• \. Have used potent inhibitors or inducers of CYP3A4, CYP2C19 or CYP1A2 within the 14 days prior to randomization or are still requiring continued use of such agents.
• \. Individuals currently receiving warfarin or other oral anticoagulants (excluding those who use low-dose anticoagulants to maintain patency of central venous access or prevent deep vein thrombosis).
• \. Individuals who are unable to undergo enhanced MRI (such as those with pacemakers, metal dentures, claustrophobia, contrast agent allergies, etc.).
• \. Individuals with evidence or medical history of bleeding tendency within 2 months prior to randomization.
• \. Individuals with urine protein ≥ 2+, and 24-hour quantitative urine protein ≥ 1.0 g/24 h upon testing.
• \. History of acquired immunodeficiency syndrome or HIV antibody positivity in the past; Active hepatitis C; Active hepatitis B.
• \. Individuals with poorly healing wounds or ulcers, or fractures that require treatment or exhibit poor healing.
• \. Within 14 days prior to randomization, there were severe chronic or active infections (including tuberculosis infections) that required intravenous injection of antibacterial, antifungal or antiviral therapy.
• \. Individuals with cardiovascular and cerebrovascular diseases of significant clinical significance.
• \. Have undergone surgery of major vital organs within 28 days prior to randomization (excluding puncture biopsy).
• \. Individuals with swallowing difficulties or known medication absorption disorders.

Sponsors & Collaborators

• Shanghai Runshi Pharmaceutical Technology Co., Ltd: lead

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, open-label, multicenter, Phase III clinical trial. Participants with recurrent or progressive high-grade meningioma (WHO Grade II and III) who have received surgical resection and radiotherapy and are not eligible for local therapy judged by investigator will be randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group) treatment.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): October 15, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05