A Phase III Study of SYHA1813 for Recurrent or Progressive High-Grade Meningiomas

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SYHA1813
  • Investigator's Choice Treatment

Treatment groups

136 Participants
are divided into 2 treatment groups

Locations

This trial has no locations