First-in-Human Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
This study is being done to determine if the investigational radiotracer called 111In-XYIMSR-01 is helpful in detecting clear cell renal cell carcinoma tissue in your body when used during a SPECT-CT Scan
• 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