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 range18 Years

SexALL

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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.
✕. 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).
✕. Inability to undergo contrast-enhanced MRI

What they're measuring

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

Timeframe: Up to approximately 3years

Trial details

NCT IDNCT06739213

SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Clinical Trials Information Group officer

86-0311-69085587 ctr-contact@cspc.cn

View on ClinicalTrials.gov More Recurrent or Progressive High Grade Meningioma trials