Meningioma Clinical Trials

⁃ STEP 1 REGISTRATION

• Aged \>= 18 years

• Histologically confirmed diagnosis of WHO grade 1-3 meningioma

• Disease progression following at least one prior surgical intervention (biopsy or resection) and at least one prior course of radiation.

• The patient is not considered a candidate for additional surgery and/or radiation or the patient has declined additional surgery and/or radiation.

• Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan defined as at least one lesion with two perpendicular diameters measuring ≥10 mm on two or more axial slices (≤ 5 mm interslice thickness, ≤ 1 mm interslice gap) per current RANO meningioma criteria

• Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as:

• ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or

• Development of a new measurable lesion

• The following scans must be available for submission for central radiology review:

• Pre-progression gadolinium-enhanced MRI brain scan no older than 12 months (379 days) that serves as a reference for evaluation of radiographic disease progression

• Progression gadolinium-enhanced MRI brain scan

⁃ STEP 2 REGISTRATION

• Progression of disease determined by central radiology review per current RANO meningioma criteria, defined as:

• ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or

• Development of a new measurable lesion.

• \[68Ga\]Ga-DOTATATE uptake on PET-CT. Positive uptake is defined as uptake at least as high as liver, based on the uptake in at least one target lesion.

• Both the patient and investigator must agree that the patient will NOT receive SSTR2-targeted therapy, surgical resection, or radiation therapy until progression of disease while on study treatment.

• Patients must be willing and able to undergo regular MRI scans of the brain and \[68Ga\]Ga-DOTATATE PET-CT imaging during the study.

• Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment).

• Adequate organ and bone marrow function as defined below (within 28 days prior to step 2 registration):

• Absolute neutrophil count (ANC) ≥ 1500/mm3

• Platelet count ≥ 75,000/mm3

• Hemoglobin ≥ 8 g/dL

• Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min

• AST (SGOT) and ALT (SGPT) ≤ 3 x the laboratory upper limit of normal (ULN)

• Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN)

• Potassium within normal limits.