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New hope for tough brain tumors: experimental drug SYHA1813 faces off against standard care

NCT ID NCT07613450

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.