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89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE2

89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors

Phase 2, Multicenter, Open-Label Study of 89Zr-girentuximab for PET/CT Imaging of Tumors Likely to Express High Levels of CAIX

NCT05563272•Telix Pharmaceuticals (Innovations) Pty Ltd

View on ClinicalTrials.gov

Summary

A prospective, open-label, phase 2 study to explore CAIX expression through 89Zirconium-labelled girentuximab deferoxamine (89Zr-girentuximab) PET/CT imaging in patients with solid tumors.

Eligibility

Age

18 - 95 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All participants must meet the following criteria:
•1. Written and voluntarily given Informed Consent.
•2. Male or female ≥18 years of age at time of consent.
•3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
•4. Participants must have proven tumors of the following types, but not limited to:
•* Cervical cancer;
•* Colorectal cancer;
•* Esophageal SCC and esophageal/esophagogastric junction adenocarcinoma;
•* Gastric adenocarcinoma;
•* GBM;
+16 more criteria

Exclusion Criteria

•Participants will be excluded from participation in the study if one or more of the following criteria are met:
•1. Have been administered any radionuclide within 10 half-lives (of the radionuclide) prior to the intended administration of 89Zr-girentuximab (i.e., within 10 half-lives of Day 0);
•2. Have been exposed to any CAIX targeting compound (diagnostic/therapeutic) in the prior 3 months;
•3. Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator;
•4. Have any clinically significant abnormalities detected during screening laboratory tests or physical exam that, in the opinion of the Investigator, would adversely affect the participant's ability to participate in the study;
•5. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study;
•6. Have been exposed to any antineoplastic treatment from Day 0 (89Zr-girentuximab dosing) to completion of 89Zr-girentuximab PET/CT imaging (Day 5 ± 2 days);
•7. Be a female who is pregnant or breastfeeding;
•8. Have a known allergy, hypersensitivity, or intolerance to girentuximab, desferrioxamine (DFO), or any of the components of the investigational agent;
•9. Have renal insufficiency with a glomerular filtration rate (GFR) ≤45 milliliters/min/1.73m2
+1 more criteria

Locations (10)

University of California, Los Angeles(UCLA)

Los Angeles, California, United States

Biogenix Molecular, LLC

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Munson Medical Center

Traverse City, Michigan, United States

University Hospitals Cleveland Medical Center (UHCMC)

Cleveland, Ohio, United States

Kettering Health Research Institute

Kettering, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Austin Radiological Association (ARA)

Austin, Texas, United States

Carilion Clinic

Roanoke, Virginia, United States

Inland Imaging

Spokane, Washington, United States

Key Dates

Start Date

June 6, 2023

Primary Completion Date

May 9, 2025

Completion Date

May 9, 2025

Last Updated

July 10, 2025

Enrollment

ACTUAL participants

Conditions

Cervical CancerColorectal CancerEsophageal CancerGastric CancerGlioblastoma MultiformeCholangiocarcinomaHepatocellular CarcinomaHead and Neck Squamous Cell CarcinomaNasopharyngeal CarcinomaNon Small Cell Lung CancerSmall Cell Lung CancerEpithelial Ovarian CancerPancreatic Ductal AdenocarcinomaSoft Tissue SarcomaGastric AdenocarcinomaMalignant Mesothelioma (MM)Von Hippel LindauBladder CancerBladder Urothelial Carcinoma

Interventions

89Zr-girentuximab for PET/CT imaging of CAIX positive tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors

Inclusion Criteria

Exclusion Criteria

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