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

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

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.

Study Overview

• Status: Terminated
• Conditions: Soft Tissue Sarcoma; Cervical Cancer; Nasopharyngeal Carcinoma; Small Cell Lung Cancer; Hepatocellular Carcinoma; Gastric Cancer; Colorectal Cancer; Esophageal Cancer; Glioblastoma Multiforme; Gastric Adenocarcinoma; Non Small Cell Lung Cancer; Cholangiocarcinoma; Bladder Cancer; Epithelial Ovarian Cancer; Head and Neck Squamous Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Bladder Urothelial Carcinoma; Von Hippel Lindau; Malignant Mesothelioma (MM)
• Intervention / Treatment: Diagnostic test: 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles(UCLA)
  • Florida
    • Miami, Florida, United States, 33165
      • Biogenix Molecular, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center (UHCMC)
    • Kettering, Ohio, United States, 45429
      • Kettering Health Research Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Radiological Association (ARA)
  • Virginia
    • Roanoke, Virginia, United States, 24018
      • Carilion Clinic
  • Washington
    • Spokane, Washington, United States, 99208
      • Inland Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;
   • 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

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
10. Be a vulnerable participant (e.g., being in detention).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 89Zr-TLX250	Diagnostic test: 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors; On Day 0, participants will receive a single administration of 89Zr-girentuximab (37 Megabecquerel (MBq) [1mCi] ± 10%, containing a mass dose of 10 mg of girentuximab).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of 89Zr-girentuximab uptake within individual tumor deposits	This outcome will be evaluated on all patients by using a PET/CT machine to qualitatively assess (yes / no) the uptake of the 89Zr-girentuximab uptake within individual tumor deposits.	Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. This assessment will be conducted throughout the patient dosing and imaging period, an average of 18 months
Quantitative assessment of 89Zr-girentuximab uptake within individual tumor deposits	This outcome will be evaluated on all patients by using a PET/CT machine to quantitatively assess the uptake of the 89Zr-girentuximab uptake within individual tumor deposits.	Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. This assessment will be conducted throughout the patient dosing and imaging period, an average of 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab	This outcome will be measured as beats per minute on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, at most 7 days.
To evaluate safety parameter of blood pressure in patients administered with 89Zr-girentuximab.	This outcome will be measured as mmHg on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
To evaluate safety parameter related to Liver function in patients administered 89Zr-girentuximab	This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
To evaluate safety parameter related to Renal function in patients administered 89Zr-girentuximab	This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
To evaluate safety parameter related to Full Blood Count in patients administered 89Zr-girentuximab	This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.

Collaborators and Investigators

• Sponsor: Telix Pharmaceuticals (Innovations) Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): May 9, 2025
• Study Completion (Actual): May 9, 2025

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Stomatognathic Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Neoplasms by Histologic Type; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Otorhinolaryngologic Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Neoplasms, Connective and Soft Tissue; Carcinoma, Squamous Cell; Ovarian Neoplasms; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma, Ovarian Epithelial; Squamous Cell Carcinoma of Head and Neck; Mesothelioma, Malignant; Carcinoma; Lung Neoplasms; Mesothelioma; Glioblastoma; Cholangiocarcinoma; Adenocarcinoma; Small Cell Lung Carcinoma; Sarcoma
• Other Study ID Numbers: 89Zr-TLX250-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No