A Phase III Study of SYHA1813 for Recurrent or Progressive High-Grade Meningiomas (NCT07613450) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase III Study of SYHA1813 for Recurrent or Progressive High-Grade Meningiomas
136 participantsStarted 2026-05-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Aged \>= 18 years.
* 2\. Histologically confirmed WHO grade II/III meningioma (WHO CNS 5th) that is progressive or recurrent.
* 3\. Individuals must have received surgery and radiation therapy.
* 4\. There is at least one measurable intracranial tumor lesion in the baseline period (RANO-meningioma).
* 5\. KPS≥60.
* 6\. The expected survival time is \>=3 months.
* 7\. The organ function level and related laboratory indicators must meet requirement.
* 8\. 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.
Exclusion Criteria:
* 1\. Individuals who are known to have severe allergic reaction to the study drug or any other ingredients/excipients in the formulation.
* 2\. Meets one of the following conditions: patients with brainstem involvement or extracranial metastasis; patients with severe brain herniation or at risk of brain herniation.
* 3\. History of other malignant tumors within 3 years or concurrent active malignant tumors.
* 4\. The toxic reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade 1.
* 5\. 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.
* 6\. Individuals currently receiving warfarin or other oral anticoagulants (excluding those who use low-dose anticoagulants to maintain patency of central venou…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) as Assessed by RANO Criteria and Evaluated by BIRC