High Grade MeningiomaPhase 3NCT07613450
A Phase III Study of SYHA1813 for Recurrent or Progressive High-Grade Meningiomas
A Phase 3 study testing SYHA1813 and Investigator's Choice Treatment in people with High Grade Meningioma, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Meningioma
- What is being tested?
- SYHA1813 and Investigator's Choice Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 15 Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SYHA1813 vs Investigators' Choice Treatment in Patients With Recurrent or Progressive High-Grade Meningiomas: A Randomized, Controlled, Multicenter, Phase III Study
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.
Read the detailed description
Approximately136 participants with recurrent or progressive high-grade meningioma who have received surgical resection and radiotherapy will be enrolled and randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group) treatment. The primary endpoint is progression-free survival (PFS) assessed by blinded Independent Review Committee (BIRC) using the Response Assessment in Neuro-Oncology Working Group (RANO criteria) for meningioma.
- Conditions
- High Grade Meningioma
- Being tested
- SYHA1813, Investigator's Choice Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHA1813Drug
SYHA1813 20mg QD
Investigator's Choice TreatmentDrug
Investigator's Choice Treatment：bevacizumab, temozolomide or hydroxyurea
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | SYHA1813 Receives: Drug: SYHA1813 |
| Control group | Active comparator | Investigator's Choice Treatment Receives: Drug: Investigator's Choice Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) as Assessed by RANO Criteria and Evaluated by BIRC
Measured: Up to approximately 4 years
Secondary outcomes (12)
PFS as Assessed by RANO Criteria and Evaluated by investigators
Measured: Up to approximately 4 years
Overall Survival (OS)
Measured: Up to approximately 4 years
Overall Survival Rate at 12 Months (OS-12)
Measured: Up to approximately 4 years
Progression Free Survival Rate at 6 Months (PFS-6) as Assessed by RANO Criteria
Measured: Up to approximately 4 years
Objective Response Rate (ORR) as Assessed by RANO Criteria
Measured: Up to approximately 4 years
Disease Control Rate (DCR) as Assessed by RANO Criteria
Measured: Up to approximately 4 years
Frequency and severity of TEAEs and SAEs
Measured: Up to approximately 4 years
Cmax of SYHA1813
Measured: Cycles 1, 2, 3
Tmax of SYHA1813
Measured: Cycles 1, 2, 3
AUClast of SYHA1813
Measured: Cycles 1, 2, 3
AUCinf of SYHA1813
Measured: Cycles 1, 2, 3
t1/2 of SYHA1813
Measured: Cycles 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start20 May 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion15 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Runshi Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613450
- Sponsor's protocol ID
- SYHA1814-006
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYHA1813 vs Investigators' Choice Treatment in Patients With Recurrent or Progressive High-Grade Meningiomas: A Randomized, Controlled, Multicenter, Phase III Study
- ClinicalTrials.gov ID
- NCT07613450
- Acronym / sponsor ID
- SYHA1814-006
- Conditions
- High Grade Meningioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Shanghai Runshi Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 15 Oct 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately136 participants with recurrent or progressive high-grade meningioma who have received surgical resection and radiotherapy will be enrolled and randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group) treatment. The primary endpoint is progression-free survival (PFS) assessed by blinded Independent Review Committee (BIRC) using the Response Assessment in Neuro-Oncology Working Group (RANO criteria) for meningioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: SYHA1813SYHA1813 |
| Control group | Active comparator | Drug: Investigator's Choice TreatmentInvestigator's Choice Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYHA1813SYHA1813 20mg QD | Drug | Experimental group |
| Investigator's Choice TreatmentInvestigator's Choice Treatment：bevacizumab, temozolomide or hydroxyurea | Drug | Control group |
Primary outcome
Progression-Free Survival (PFS) as Assessed by RANO Criteria and Evaluated by BIRC
Time frame: Up to approximately 4 years
12 secondary outcomes
PFS as Assessed by RANO Criteria and Evaluated by investigators
Time frame: Up to approximately 4 years
Overall Survival (OS)
Time frame: Up to approximately 4 years
Overall Survival Rate at 12 Months (OS-12)
Time frame: Up to approximately 4 years
Progression Free Survival Rate at 6 Months (PFS-6) as Assessed by RANO Criteria
Time frame: Up to approximately 4 years
Objective Response Rate (ORR) as Assessed by RANO Criteria
Time frame: Up to approximately 4 years
Disease Control Rate (DCR) as Assessed by RANO Criteria
Time frame: Up to approximately 4 years
Frequency and severity of TEAEs and SAEs
Time frame: Up to approximately 4 years
Cmax of SYHA1813
Time frame: Cycles 1, 2, 3
Tmax of SYHA1813
Time frame: Cycles 1, 2, 3
AUClast of SYHA1813
Time frame: Cycles 1, 2, 3
AUCinf of SYHA1813
Time frame: Cycles 1, 2, 3
t1/2 of SYHA1813
Time frame: Cycles 1, 2, 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SYHA1813 and Investigator's Choice Treatment in people with High Grade Meningioma, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) as Assessed by RANO Criteria and Evaluated by BIRC (time frame: Up to approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.