111In-XYIMSR-01 for Kidney Cancer

Overseen By Jasmine Brooks

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Radioisotopes

Disqualifiers: Systemic therapy, Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiotracer, 111In-XYIMSR-01, to determine its effectiveness in detecting kidney cancer, specifically clear cell renal cell carcinoma, during a SPECT-CT scan. The main goal is to enhance the detection of cancerous tissue through advanced imaging. This trial may suit individuals diagnosed with clear cell kidney cancer who have multiple disease sites visible on recent scans. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new radiotracer.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had systemic therapy for kidney cancer within the last 12 months or any radioisotope treatment recently.

What prior data suggests that 111In-XYIMSR-01 is safe for detecting kidney cancer?

Research shows that 111In-XYIMSR-01 is being tested for safety and side effects using a special scan called SPECT/CT, which helps doctors see kidney cancer more clearly. In earlier studies, scientists examined how the body processes this treatment and checked for any harmful effects. These studies ensure the treatment can be safely tested in humans.

Since the trial is in its early stages, there is limited data from humans. This phase focuses on ensuring the treatment's safety and determining the right dose. So far, no serious side effects have been reported, but the trial will continue to monitor for any issues. Participants will be closely monitored to ensure their safety during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for kidney cancer, which typically include surgery, chemotherapy, and targeted therapies like tyrosine kinase inhibitors, 111In-XYIMSR-01 introduces a novel approach by using a radioactive tracer combined with SPECT/CT imaging. This treatment is unique because it leverages a radiopharmaceutical agent that specifically targets cancer cells, potentially allowing for both precise imaging and targeted therapy. Researchers are excited about this treatment because it could offer more accurate detection and treatment of kidney cancer, potentially leading to better outcomes and fewer side effects compared to conventional therapies.

What evidence suggests that 111In-XYIMSR-01 is effective for detecting kidney cancer?

Research has shown that 111In-XYIMSR-01, the investigational treatment in this trial, is a promising tool for detecting tumors in kidney cancer. It targets a protein called carbonic anhydrase IX, which is abundant in clear cell renal cell carcinoma, a type of kidney cancer. Early results indicate that this agent effectively highlights cancer cells during scans. Studies have consistently detected tumors with high levels of carbonic anhydrase IX using this agent, suggesting it could reliably identify kidney cancer. This evidence supports the use of 111In-XYIMSR-01 as an effective method for locating cancerous areas in the body during scans. ^{1 3 4 5 6}

Who Is on the Research Team?

Yasser Ged, MBBS

Principal Investigator

Johns Hopkins University SKCCC

Are You a Good Fit for This Trial?

Adults diagnosed with metastatic clear cell renal cell carcinoma, who have 2-10 detectable disease sites and haven't had systemic therapy for ccRCC in the last year. Participants need normal liver function, adequate blood counts, and a creatinine clearance of at least 50 mL/min. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

I have 2-10 cancer sites, each larger than 1.5 cm, confirmed by recent scans.

I am either male or female.

I am 18 years old or older.

Exclusion Criteria

I haven't had systemic therapy for kidney cancer in the last 12 months.

I haven't received any radioisotope treatment recently.

Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

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

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 111In-XYIMSR-01

Trial Overview The trial is testing an investigational radiotracer called 111In-XYIMSR-01 used during SPECT-CT scans to see if it's effective in detecting clear cell renal cell carcinoma tissues within the body.

How Is the Trial Designed?

Group I: A (111In-XYIMSR-01) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129612/

Process validation, cGMP production, dosimetry, and ... XYIMSR-01 is a promising single-photon emission computed tomography (SPECT) imaging agent for identification of tumors that overexpress carbonic anhydrase IX.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07062549

NCT07062549 | Study of 111In-XYIMSR-01 SPECT/CT in ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4741798/

Imaging of carbonic anhydrase IX with an 111In-labeled dual ... Here we report the synthesis and in vivo performance of [111In]XYIMSR-01, a modified dual-motif CAIX inhibitor with improved tumor uptake and pharmacokinetics ...

4. researchgate.net researchgate.net/publication/282344372_Imaging_of_carbonic_anhydrase_IX_with_an_111In-labeled_dual-motif_inhibitor

Imaging of carbonic anhydrase IX with an 111In-labeled ... We synthesized [111In]XYIMSR-01 in 73.8-75.8% (n = 3) yield with specific radioactivities ranging from 118 - 1,021 GBq/μmol (3,200-27,600 Ci/ ...

5. mdpi.com mdpi.com/1422-0067/21/19/7146

Carbonic Anhydrase IX in Renal Cell Carcinoma, ... Histological outcomes showed 12 ccRCC, all hyperfluorescent at any dose, all PET/CT positives and all presenting a stronger signal with per operative gamma ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-01135

An Investigational Scan (111In-XYIMSR-01 SPECT/CT) for ... This phase I trial tests the safety and side effects of 111In-XYIMSR-01 single photon emission computed tomography (SPECT)/computed tomography (CT) to ...