A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma (NCT06739213) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma
56 participantsStarted 2025-01-31
Plain-language 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.
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
. Aged \>= 18 years;
. Histologically confirmed WHO grade II/III meningioma (WHO CNS 5th)
. There is at least one measurable 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 requirements (no blood transfusion within 2 weeks):
. Female participants of childbearing potential must have a negative the blood pregnancy test results of within 7 days prior to randomization and agree to use reliable and effective contraception during the study treatment period and for at least 3 months after the last study treatment (or as required by the drug's instructions). Male participants with partners of childbearing potential must agree to use reliable and effective contraception during the study treatment period and for at least 3 months after the last study treatment (or as required by the drug's instructions).
Exclusion criteria
. Patients who are known or suspected to be allergic to the test drug or its components;
. Meets one of the following conditions: patients with brainstem involvement; patients with severe brain herniation or at risk of brain herniation; patients with extracranial metastasis during the screening period.
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
the Progression-free survival (PFS) at 6-month（PFS-6）as evaluated by investigator (RANO-meningioma)
. A history of any other malignant tumors within 3 years (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured carcinoma in situ);
. Use of glucocorticoids at an equivalent dose exceeding 5mg of dexamethasone within 7 days prior to randomization.
. The toxicity of previous anti-tumor treatments has not recovered to Grade1(including brain edema after radiotherapy), with the exception of hair loss, uncomplicated laboratory abnormalities that do not require medical intervention, and other adverse reactions deemed by the investigator not to affect the safety of the study medication.;
. Use of a strong CYP3A4 inhibitor within 14 days prior to randomization or ongoing use of such inhibitors.
. Current use of warfarin or other oral anticoagulants (except for low-dose anticoagulants used to maintain central venous access or prevent deep vein thrombosis).