A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SYHA1813
- Investigator's Choice Treatment
Treatment groups
56 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov