Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide

Inclusion Criteria:

• Informed Consent as documented by signature
• Participants of any gender and of age > 18 years
• Female participants capable of giving birth (who are not surgically sterilized or areless than 2 years in their menopause) must use a medically accepted contraceptive andmust agree to use it during and till 3 months after the treatment. As acceptablecontraceptive count sexual abstinence or double contraceptive methods: hormonalcontraceptive (oral, transdermal, implants or injections) in combination with barriermethods (spiral, condom, diaphragm)
• Male participants must use medically accepted contraceptive during and till 3 monthsafter treatment
• The participants' Karnofsky Performance Status must be ≥ 60
• The participants must be patients with a histologically or clinically confirmed (MRI +somatostatin receptor imaging) recurrent or progressive meningioma
• There must be no other standard therapeutic alternatives for the participants
• The participants tumour must be measurable according to RECIST v1.1 with a minimaldiameter of 1.0 cm.
• The participants must have a confirmed expression of somatostatin receptor (SSTR) on 68Ga- DOTATOC positron emission computed tomography (PET)/CT scan
• Blood parameter criteria are: h) Leucocytes ≥ 3109/L i) Haemoglobin ≥ 80 g/L j) Thrombocytes ≥ 90109/L k)Estimated glomerular filtration rate ≥ 50 ml/min l) Albumin > 25g/L m) alanineaminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤ 5 times upper standard value n) Bilirubin ≤ 2 times upper standard value

Exclusion Criteria:

• Known intolerance against 177Lu, DOTA, JR11, TOC or against one of the components of 177Lu-DOTA-JR11 or 177Lu-DOTATOC
• Ongoing infection at the screening visit or a serious infection in the past 4 weeks
• Administration of another investigational product in the last 60 days before Visit 1Day 1
• Prior or planed administration of a therapeutic radio-pharmaceutical during 8half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoingstudy
• Any extensive Radiotherapy involving bone marrow over the last 3 months beforeinclusion to the study
• Chemotherapy in the last 2 months before inclusion
• Pregnant or breastfeeding female patients. A pregnancy test will be performed in allwomen of child bearing potential.
• Any uncontrolled significant medical, psychiatric or surgical condition (activeinfection, unstable angina pectoris, cardiac arrhythmia, poorly controlledhypertension, poorly controlled diabetes mellitus [HbA1c ≥ 9%], uncontrolledcongestive heart disease, etc.) or laboratory findings that might jeopardize thepatient's safety or that would limit compliance with the objectives and assessments ofthe study. Any mental conditions which prevent the patient from understanding thetype, extent and possible consequences of the study and/or an uncooperative attitudefrom the patient.