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

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

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.