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RecruitingPhase 1NCT07062549

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

6 participants

Start Date

Jan 26, 2022

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria14

  • 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
  • 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 Criteria5

  • 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.

Interventions

DRUG111In-XYIMSR-01

Unite Dose: 10.5±1 mCi of 111In-XYIMSR-01 Route of administration: Intravenous catheter placed in an antecubital vein or an equivalent venous access

Locations(1)

Johns Hopkins University

Baltimore, Maryland, United States

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