TerminatedPhase 2NCT05563272
Official study title

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

Study 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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studied89Zr-girentuximab for PET/CT imaging of CAIX positive tumors

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · Mesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 10, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Telix Pharmaceuticals (Innovations) Pty Ltd

Study sponsor

01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 2
Sponsor
Telix Pharmaceuticals (Innovations) Pty Ltd
Interventions being studied
Diagnostic Test: 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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;
  • Head and neck SCC and nasopharyngeal carcinoma;
  • cholangiocarcinoma and hepatocellular carcinoma;
  • non-small cell lung cancer;
  • small cell lung cancer;
  • epithelial ovarian carcinoma;
  • pancreatic ductal adenocarcinoma;
  • Soft tissue sarcoma;
  • malignant mesothelioma;
  • confirmed diagnosis of VHL disease with VHL germline alteration and at least one VHL-related lesion. 5. Have at least one non-central nervous system (CNS), measurable target lesion as defined per RECIST 1.1 and documented by SOC conventional imaging, performed within 60 days (+14 days) prior to Day 0 (excepting participants with GBM or hemangioblastoma, given that all lesions may be in the CNS, such lesions assessed by RANO); 6. Have agreed not to receive another investigational product while participating in the present study, defined as signing the informed consent form (ICF), until completion of the last study visit; 7. Have negative serum pregnancy tests if a female of childbearing potential at screening and have a confirmatory negative urine pregnancy test result within 24 hours prior to receiving investigational product. Female participants of non-child- bearing potential must provide evidence by fulfilling one of the following criteria at screening:
  • Be post-menopausal, defined as more than 50 years of age and amenorrheic for at least 12 months since cessation of all exogenous hormonal treatments;
  • Be a woman under 50 years of age and considered postmenopausal given amenorrhea for 12 months or more since cessation of exogenous hormonal treatments and having luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range by institutional SOC;
  • Have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation; and 8. Have consented to practice highly effective method of contraception until a minimum of 42 days after 89Zr-girentuximab administration
Reasons someone may not be able to joinExclusion 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 10. Be a vulnerable participant (e.g., being in detention).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California, Los Angeles(UCLA)Los Angeles, California
  • Biogenix Molecular, LLCMiami, Florida
  • Massachusetts General HospitalBoston, Massachusetts
  • Munson Medical CenterTraverse City, Michigan
  • University Hospitals Cleveland Medical Center (UHCMC)Cleveland, Ohio
  • Kettering Health Research InstituteKettering, Ohio
  • University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
  • Austin Radiological Association (ARA)Austin, Texas
  • Carilion ClinicRoanoke, Virginia
  • Inland ImagingSpokane, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 10, 2025. Always confirm current availability with the study team.

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