Study Stopped
Indication scouting for TLX250-CDx will continue in theranostic studies, with a therapeutic component in the study design.
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
1 other identifier
interventional
11
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2023
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedStudy Start
First participant enrolled
June 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2025
CompletedJuly 10, 2025
July 1, 2025
1.9 years
September 23, 2022
July 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab
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.
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
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
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
Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
Study Arms (1)
89Zr-TLX250
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- All participants must meet the following criteria:
- Written and voluntarily given Informed Consent.
- Male or female ≥18 years of age at time of consent.
- Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
- 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;
- +11 more criteria
You may not qualify if:
- Participants will be excluded from participation in the study if one or more of the following criteria are met:
- 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);
- Have been exposed to any CAIX targeting compound (diagnostic/therapeutic) in the prior 3 months;
- 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;
- 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;
- Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study;
- 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);
- Be a female who is pregnant or breastfeeding;
- Have a known allergy, hypersensitivity, or intolerance to girentuximab, desferrioxamine (DFO), or any of the components of the investigational agent;
- Have renal insufficiency with a glomerular filtration rate (GFR) ≤45 milliliters/min/1.73m2
- Be a vulnerable participant (e.g., being in detention).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of California, Los Angeles(UCLA)
Los Angeles, California, 90095, United States
Biogenix Molecular, LLC
Miami, Florida, 33165, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
University Hospitals Cleveland Medical Center (UHCMC)
Cleveland, Ohio, 44106, United States
Kettering Health Research Institute
Kettering, Ohio, 45429, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
Austin Radiological Association (ARA)
Austin, Texas, 78705, United States
Carilion Clinic
Roanoke, Virginia, 24018, United States
Inland Imaging
Spokane, Washington, 99208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2022
First Posted
October 3, 2022
Study Start
June 6, 2023
Primary Completion
May 9, 2025
Study Completion
May 9, 2025
Last Updated
July 10, 2025
Record last verified: 2025-07