Renal Cell Carcinoma (Kidney Cancer)Phase 1NCT07062549
Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell
A Phase 1 study testing 111In-XYIMSR-01 in people with Renal Cell Carcinoma (Kidney Cancer), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (Kidney Cancer)
- What is being tested?
- 111In-XYIMSR-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jasmine Brooks contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Yasser Ged, MBBS, 410-955-8893, yged1@jhmi.edu
Yasser Ged, MBBS
About this study
Official title: 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
- Conditions
- Renal Cell Carcinoma (Kidney Cancer)
- Being tested
- 111In-XYIMSR-01
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
111In-XYIMSR-01Drug
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
| Study group | Role | What they receive |
|---|---|---|
| A (111In-XYIMSR-01) | Experimental | Participants who receive 111In-XYIMSR-01 dosing and SPECT/CT imaging Receives: Drug: 111In-XYIMSR-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
To evaluate the safety, tolerability, and feasibility of SPECT/CT imaging with 111In-XYIMSR-01 measured by all adverse events according to CTCAE version 5.
Measured: From enrollment to the end of treatment at 1 week
Secondary outcomes (4)
Biodistribution assessed by SPECT/CT images
To determine the biodistribution and radiation dosimetry of 111In-XYIMSR-01
Measured: From enrollment to the end of treatment at 1 week
Radiation Dosimetry assessed by SPECT/CT images
To determine radiation dosimetry of 111In-XYIMSR-01
Measured: From enrollment to the end of treatment at 1 week
Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time
To quantify the total radioactivity (expressed in counts per minute [CPM]) in plasma samples at specified time points following injection of 111In-XYIMSR-01
Measured: From enrollment to the end of treatment at 1 week
Number of lesions detected
Investigating the role of 111In-XYIMSR-01 SPECT/CT as a diagnostic assessment tool in comparison to conventional imaging. To compare the number of lesions detected with 111In-XYIMSR-01 SPECT/CT in comparison to conventional imaging all imaging modalities
Measured: From enrollment to the end of treatment at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start26 Jan 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (Kidney Cancer)Studies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasser Ged, MBBS, Principal investigator, Johns Hopkins University SKCCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062549
- Sponsor's protocol ID
- J20116
- Other IDs
- IRB00237314
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07062549
- Acronym / sponsor ID
- J20116
- Conditions
- Renal Cell Carcinoma (Kidney Cancer)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A (111In-XYIMSR-01) | Experimental | Drug: 111In-XYIMSR-01Participants who receive 111In-XYIMSR-01 dosing and SPECT/CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 111In-XYIMSR-01Unite Dose: 10.5±1 mCi of 111In-XYIMSR-01 Route of administration: Intravenous catheter placed in an antecubital vein or an equivalent venous access | Drug | A (111In-XYIMSR-01) |
Primary outcome
Number of adverse events
Time frame: From enrollment to the end of treatment at 1 week
To evaluate the safety, tolerability, and feasibility of SPECT/CT imaging with 111In-XYIMSR-01 measured by all adverse events according to CTCAE version 5.
4 secondary outcomes
Biodistribution assessed by SPECT/CT images
Time frame: From enrollment to the end of treatment at 1 week
Radiation Dosimetry assessed by SPECT/CT images
Time frame: From enrollment to the end of treatment at 1 week
Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time
Time frame: From enrollment to the end of treatment at 1 week
Number of lesions detected
Time frame: From enrollment to the end of treatment at 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasmine Brooks contact
Yasser Ged, MBBS principal investigator
Johns Hopkins University SKCCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 111In-XYIMSR-01 in people with Renal Cell Carcinoma (Kidney Cancer), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasser Ged, MBBS (410-955-8893, yged1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: From enrollment to the end of treatment at 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.