Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer

Inclusion criteria: * Patients with proven advanced and progressive RCC of the clear cell type * Presence of RECIST v.1.1 evaluable lesions, all \< 5 cm * Performance status: Karnofsky \> 70 % * Laboratory values: • White blood cells (WBC) \> 3.5 x 109/l • Platelet count \> 150 x 109/l • Hemoglobin \> 6 mmol/l • Total bilirubin \< 2 x upper limit of normal (ULN) • ASAT, ALAT \< 3 x ULN (\< 5 x ULN if liver metastases present) • MDRD ≥ 40 ml/min * Negative pregnancy test for women of childbearing potential (urine or serum) * Age over 18 years * Written informed consent Exclusion criteria: * Known or suspected CNS metastases including leptomeningeal metastases. History or clinical evidence of (CNS) metastases (unless they are previously-treated CNS metastases and patients meet all 3 of the following criteria: are asymptomatic, have had no evidence of active CNS metastases for ≥3 months prior to enrollment, and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days) * Untreated hypercalcemia * Chemotherapy, external beam radiation, immunotherapy or angiogenesis inhibitors or mTOR inhibitors within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed , when unirradiated, evaluable lesions elsewhere are present. * Cardiac disease with New York Heart Association classification of III or IV * Patients who are pregnant, nursing or of reproductive potential and are not practicing an effect…