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 effective method of contraception
* Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator will significantly affect patients' clinical status
* Life expectancy shorter than 4 months.