RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

Inclusion Criteria: * Male or female patients of age \> 18 years * Patients with 68Ga-DOTATATE positive recurrent or progressive meningiomas, any World Health Organization (WHO) grade, who have progressed after first line treatment. * For Grade I meningioma, patients must have either: * Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bidirectional area) on imaging by 25% or more between scans separated by no more than 12 months; or * Progressive residual tumor after maximal safe resection, located at or near critical organs at-risk and considered to be high-risk for radiation injury by the treating investigator. Prior external beam radiotherapy is not required for these subjects. * For Grade II or III meningioma, subjects must have either: * Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bi-directional area) on imaging by 25% or more between scans separated by no more than 12 months or * Residual measurable disease after prior surgery without requirement of progression, or * Unsuitable for, or decline other standard of care treatment. * Positive 68Ga-DOTATATE uptake on PET/CT at baseline, defined as target lesion uptake higher than the background with SUV ratios adjusted to the liver uptake (Krenning score ≥ 2) * Presence of measurable disease defined as at least one…