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

NCT ID: NCT07062549

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2029-07-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A (111In-XYIMSR-01)

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

Group Type: EXPERIMENTAL

111In-XYIMSR-01

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yasser Ged, MBBS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University SKCCC

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yasser Ged, MBBS

Role: CONTACT

yged1@jhmi.edu

410-955-8893

Jasmine Brooks

Role: CONTACT

jbrook54@jhmi.edu

Facility Contacts

Yasser Ged, MBBS

Role: primary

yged1@jhmi.edu

410-955-8893

Other Identifiers

IRB00237314

Identifier Type: OTHER

Identifier Source: secondary_id

J20116

Identifier Type: -

Identifier Source: org_study_id