Recruiting
Phase 1

111In-XYIMSR-01

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT07062549

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

111In-XYIMSR-01

Study Details

Brief 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

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Study ID

NCT07062549

Start date

Jan 26, 2022

Status verified date

Jul, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: A (111In-XYIMSR-01)

Participants who receive 111In-XYIMSR-01 dosing and SPECT/CT imaging

Interventions

111In-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

Primary outcome measure

  • Number of adverse events [ Time Frame: From enrollment to the end of treatment at 1 week ]

Central Contacts and Locations

Central contacts

Yasser Ged, MBBS

410-955-8893yged1@jhmi.edu

Jasmine Brooks

jbrook54@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Yasser Ged, MBBS

410-955-8893yged1@jhmi.edu

Principal Investigator:

Yasser Ged, MBBS

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-07-21.