89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study

"89Zr-TLX250, is a chimeric monoclonal antibody (INN name: girentuximab) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting radiometal zirconium- 89. Girentuximab has a CAS number of 916138-87-9. The chemical formula, without the 89Zr and the desferrioxamine, is C6460H1006N1718O2018S48 with a molecular mass of 146.5 kg/mol.~89Zr-TLX250 is formulated as a solution for IV administration in glass vials at the nominal dosage strength of 37 MBq (±10%) for single IV use. The mass dose of 89Zr-TLX250 to be used in this Phase 3 study will be 10 mg, labelled with 37 MBq (±10%) 89Zr per dose."