111In-XYIMSR-01 SPECT/CT to find metastatic clear-cell kidney cancer

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

This trial tries a radioactive tracer called 111In-XYIMSR-01 during a SPECT/CT scan to see if it can find metastatic clear-cell kidney cancer in adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT07062549 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional imaging trial gives adults with histologically confirmed clear-cell renal cell carcinoma a single dose of the investigational radiotracer 111In-XYIMSR-01 followed by SPECT/CT imaging to visualize sites of disease. Eligible participants must have 2–10 measurable lesions ≥1.5 cm on recent contrast CT or MRI and meet specified laboratory safety criteria. The study will document the tracer's ability to detect known lesions and collect safety and imaging-dosimetry data. Conducted at Johns Hopkins, the protocol excludes patients who received systemic therapy for ccRCC within the prior 12 months.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed clear-cell RCC who have 2–10 measurable lesions ≥1.5 cm on recent CT/MRI, meet baseline lab requirements, and can travel to the study site are the ideal candidates.

Not a fit: Patients with non–clear-cell histology, fewer or more lesions than allowed, lesions smaller than 1.5 cm, recent systemic therapy for ccRCC within 12 months, or significant organ dysfunction are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the tracer could improve detection and localization of metastatic clear-cell kidney cancer and help guide staging or treatment planning.

How similar studies have performed: Other radiotracer imaging approaches for kidney cancer have shown promise, but 111In-XYIMSR-01 is investigational and prior human data are limited.

Eligibility criteria

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.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Yasser Ged, MBBS — Johns Hopkins University SKCCC
• Study coordinator: Yasser Ged, MBBS

Conditions Renal Cell Carcinoma