Cervical CancerPhase 2STARBURSTNCT05563272
89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors
A Phase 2 study testing 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors in people with Cervical Cancer and Colorectal Cancer, run by Telix Pharmaceuticals (Innovations) Pty Ltd at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cervical Cancer, Colorectal Cancer, Esophageal Cancer
- What is being tested?
- 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 10 sitesUnited States
- Study dates
- 6 Jun 2023to 9 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 26Show fewer
- 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.
- 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);
- 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;
- 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
- Have consented to practice highly effective method of contraception until a minimum of 42 days after 89Zr-girentuximab administration
Who cannot join
- 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;
Show all 11Show fewer
- 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).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Austin Radiological Association (ARA)
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02114
University Hospitals Cleveland Medical Center (UHCMC)
Cleveland, Ohio, 44106
Kettering Health Research Institute
Kettering, Ohio, 45429
University of California, Los Angeles(UCLA)
Los Angeles, California, 90095
Biogenix Molecular, LLC
Miami, Florida, 33165
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Carilion Clinic
Roanoke, Virginia, 24018
Inland Imaging
Spokane, Washington, 99208
Munson Medical Center
Traverse City, Michigan, 49684
About this study
Official title: 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.
- Conditions
- Cervical Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Glioblastoma Multiforme, Cholangiocarcinoma
- Being tested
- 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors
- Medical subject headings
- Uterine Cervical Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Glioblastoma, Cholangiocarcinoma, Carcinoma, Hepatocellular, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-girentuximab for PET/CT imaging of CAIX positive tumorsDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-TLX250 | Experimental | Not described Receives: Diagnostic Test: 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start6 Jun 2023
- Primary completion9 May 2025
- Study completion9 May 2025
Why it stopped: Indication scouting for TLX250-CDx will continue in theranostic studies, with a therapeutic component in the study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563272
- Sponsor's protocol ID
- 89Zr-TLX250-005
- Acronym
- STARBURST
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2022
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Open-Label Study of 89Zr-girentuximab for PET/CT Imaging of Tumors Likely to Express High Levels of CAIX
- ClinicalTrials.gov ID
- NCT05563272
- Acronym / sponsor ID
- STARBURST / 89Zr-TLX250-005
- Conditions
- Cervical Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Glioblastoma Multiforme, Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Indication scouting for TLX250-CDx will continue in theranostic studies, with a therapeutic component in the study design.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-TLX250 | Experimental | Diagnostic Test: 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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:
- 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);
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-girentuximab for PET/CT imaging of CAIX positive tumorsOn 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). | Diagnostic test | 89Zr-TLX250 |
Primary outcome
Qualitative assessment of 89Zr-girentuximab uptake within individual tumor deposits
Time frame: 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
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.
Quantitative assessment of 89Zr-girentuximab uptake within individual tumor deposits
Time frame: 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
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.
5 secondary outcomes
To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
Results and safety
The study was stopped early (reason given: Indication scouting for TLX250-CDx will continue in theranostic studies, with a therapeutic component in the study design.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 89Zr-girentuximab for PET/CT imaging of CAIX positive tumors in people with Cervical Cancer and Colorectal Cancer, run by Telix Pharmaceuticals (Innovations) Pty Ltd at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Indication scouting for TLX250-CDx will continue in theranostic studies, with a therapeutic component in the study design.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of 89Zr-girentuximab uptake within individual tumor deposits (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.