First-in-Human Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria: * Males or female sex * ≥18 years of age * Willingness to provide signed informed consent and comply with all protocol requirements * Histological confirmation of RCC with a clear cell component * 2-10 sites of disease measuring ≥1.5 cm on contrast-enhanced CT and/or MRI imaging of the chest, abdomen and pelvis performed ≤60 days prior to the date of study enrollment * Screening clinical laboratory values as specified below: * Serum bilirubin ≤ 1.5 times the upper limit of normal; for patients with known Gilbert's syndrome, ≤ 3 × ULN is permitted * ALT ≤ 3 times the upper limits of normal * AST ≤ 3 times the upper limits of normal * Creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula * Absolute neutrophil count ≥ 1,500 /mm3 * Platelets ≥100,000/ mm3 * Hemoglobin ≥ 9.0 g/dL * White blood cell count ≥ 2,000/ mm3 Exclusion Criteria: * Systemic therapy for the treatment of ccRCC within 12 months of study enrollment. * Subjects administered any radioisotope within five physical half-lives prior to study drug injection. * Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion. * Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the imaging day. * Women must not be breastfeeding.