New hope for tough brain tumors: experimental drug SYHA1813 faces off against standard care
NCT ID NCT07613450
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests a new drug called SYHA1813 against standard treatments (bevacizumab, temozolomide, or hydroxyurea) in 136 adults with recurrent or progressive high-grade meningioma. Participants must have already had surgery and radiation. The main goal is to see if SYHA1813 can delay tumor growth better than current options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SYHA1813
- What this could lead to
- If successful, this could provide a new targeted treatment option for people with recurrent high-grade meningioma, potentially slowing tumor growth better than current therapies.
- What could go wrong
- This is an early-stage Phase 3 trial with only 136 participants, so results may not apply to all patients. The drug may not prove more effective or safer than existing options, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 venous access or prevent deep vein thrombosis). * 7\. Individuals who are unable to undergo enhanced MRI (such as those with pacemakers, metal dentures, claustrophobia, contrast agent allergies, etc.). * 8\. Individuals with evidence or medical history of bleeding tendency within 2 months prior to randomization. * 9\. Individuals with urine protein ≥ 2+, and 24-hour quantitative urine protein ≥ 1.0 g/24 h upon testing. * 10\. History of acquired immunodeficiency syndrome or HIV antibody positivity in the past; Active hepatitis C; Active hepatitis B. * 11\. Individuals with poorly healing wounds or ulcers, or fractures that require treatment or exhibit poor healing. * 12\. 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. * 13\. Individuals with cardiovascular and cerebrovascular diseases of significant clinical significance. * 14\. Have undergone surgery of major vital organs within 28 days prior to randomization (excluding puncture biopsy). * 15\. Individuals with swallowing difficulties or known medication absorption disorders. * 16\. Pregnant or lactating women. * 17\. Any other conditions that may interfere with the participant's adherence to study procedures, compromise the participant's best interests in participating in the study, or affect study results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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More trials for these conditions
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