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Recurrent or Progressive High Grade MeningiomaPhase 2NCT06739213

A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma

A Phase 2 study testing SYHA1813 and Investigator's Choice Treatment in people with Recurrent or Progressive High Grade Meningioma, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SYHA1813 and Investigator's Choice Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
31 Jan 2025to 13 Jan 2028
Phase
Phase 2
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

  • 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).

Who cannot join

  • 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.
  • 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.
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  • Current use of warfarin or other oral anticoagulants (except for low-dose anticoagulants used to maintain central venous access or prevent deep vein thrombosis).
  • Inability to undergo contrast-enhanced MRI
  • Patients with evidence of bleeding tendency or medical history within 2 moths
  • Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g/24h;
  • Human immunodeficiency virus (HIV) antibody positive; active hepatitis C (anti-HCV antibody positive and HCV RNA test positive); active hepatitis B (HBV DNA test for HBsAg is positive and HBV DNA is equal to or higher than 2×10^3 IU/ml));
  • The subject has poorly healed wounds, ulcers or fractures;
  • Presence of a severe chronic or active infection (including tuberculosis and other infections).requiring intravenous antibiotic, antifungal, or antiviral treatment within 14 days prior to randomization
  • Other severe systemic diseases, including but not limited to uncontrolled diabetes, kidney disease requiring dialysis, severe liver disease (Child-Pugh class B or C), acute pancreatitis, etc.
  • Subjects with clinically significant cardiovascular and cerebrovascular diseases.
  • Underwent major organ surgery within 28 days prior to randomization (excluding biopsy procedures).
  • Received chemotherapy (including temozolomide), targeted therapy, immunotherapy, hormone therapy, or other antitumor treatments within 28 days prior to randomization; or used any NMPA-approved traditional Chinese medicine or patent Chinese medicine with anticancer activity within 14 days prior to randomization (regardless of cancer type).
  • Subjects with dysphagia or known drug absorption disorders.
  • Pregnant or lactating women.
  • Presence of other conditions that may interfere with the participant's ability to comply with the study procedures or that may not allow the participant to derive the maximum benefit from the study, or that may affect the study outcomes, such as a history of psychiatric disorders, drug or substance abuse, or any other clinically significant disease or condition.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

Official title: SYHA1813 vs Investigators' Choice as Treatment for Recurrent or Progressive High-Grade Meningioma: A Randomized, Controlled, Multicenter, Phase II Study

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.

Read the detailed description

A total of 56 participants with recurrent or progressive high-grade meningioma who are not eligible for local therapy will be enrolled. Participants will be randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group). The primary endpoint is the 6-month progression-free survival (PFS) rate assessed by investigators using the Response Assessment in Neuro-Oncology Working Group（ RANO criteria） for meningioma.

Being tested
SYHA1813, Investigator's Choice Treatment
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYHA1813Drug

    The starting dose of SYHA1813 is 20mg QD

  • Investigator's Choice TreatmentDrug

    Investigator's Choice Treatment

Study groups in NCT06739213
Study groupRoleWhat they receive
Experimental groupExperimentalSYHA1813
Receives: Drug: SYHA1813
Control groupActive comparatorInvestigator'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.

  1. the Progression-free survival (PFS) at 6-month（PFS-6）as evaluated by investigator (RANO-meningioma)

    Measured: Up to approximately 3years

Secondary outcomes (9)

  1. Progression-free survival (PFS) as evaluated by INV (RANO-meningioma)

    Measured: Up to approximately 3years

  2. Objective response rate (ORR) as evaluated by INV (RANO-meningioma)

    Measured: Up to approximately 3years

  3. Disease control rate (DCR) as evaluated by INV (RANO-meningioma)

    Measured: Up to approximately 3years

  4. Overall survival (OS)

    Measured: Up to approximately 3years

  5. Frequency and severity of TEAE and SAE

    Measured: Up to approximately 3years

  6. Maximum Plasma Concentration of SYHA1813 (Cmax)

    Measured: Up to approximately 3years

  7. The scores of the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)

    The EOTCT QLQ-C30 is designed to measure the health-related quality of life (HRQoL) across different cancer types and stages. It has demonstrated good evidence of content validity for assessing functional health, symptom burden, and health-related quality of life in patients with localized to advanced cancer. The questionnaire comprises 30 items that are combined to form five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), and six single items (appetite loss, diarrhea, constipation, dyspnea, insomnia, and financial difficulties), as well as a global health status/quality of life scale. The global health status scale is scored on a 7-point scale, while the other items are scored on a 4-point scale. Higher scores indicate a higher level of response.

    Measured: Up to approximately 3years

  8. The scores of the 20-item EORTC QLQ for Brain Neoplasm (-BN20)

    The EORTC QLQ-BN20 is a 20-item questionnaire specifically designed for assessing the health-related quality of life (HRQOL) and symptoms in patients with brain cancer, including both primary brain tumors and brain metastases. Within the EORTC framework, there is a distinction between functional scales (e.g., "Emotional Functioning") and symptom scales (e.g., "Pain"). High scores on functional scales indicate better functioning, while high scores on symptom scales indicate a greater symptom burden.

    Measured: Up to approximately 3years

  9. The score of The Neurologic Assessment in Neuro-Oncology (NANO) scale

    The NANO scale evaluates 9 major domains of neurologic function that are most relevant to patients with supratentorial, infratentorial, and brainstem tumors, including gait, strength, upper extremity ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior. As designed, the gait domain includes assessment of lower extremity ataxia. Each domain is subdivided into 3 or 4 levels of function with scores based on discrete quantifiable measures. Thus, levels of function for each domain range from 0 to 2 or 0 to 3. A score of 0 indicates normal function, while the highest score indicates the most severe level of deficit for that domain. Levels of function are distinguished by significant and measurable differences in order to avoid misinterpretation of subtle or nonspecific changes.

    Measured: Up to approximately 3years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start31 Jan 2025 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion13 Jan 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, controlled, open-label, multicenter, Phase II clinical trail, randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group).
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06739213
Sponsor's protocol ID
SYHA1814-004
Status last verified
Dec 2024
First submitted
9 Dec 2024
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SYHA1813 and Investigator's Choice Treatment in people with Recurrent or Progressive 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 7 inclusion and 20 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 18 Dec 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

the Progression-free survival (PFS) at 6-month（PFS-6）as evaluated by investigator (RANO-meningioma) (time frame: Up to approximately 3years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06739213.

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 18 Dec 2024.

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