Clear Cell Renal Cell CarcinomaPhase 1ZIRDOSE-CPNCT05861778
Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
A Phase 1 study testing 89Zr-Girentuximab in people with Clear Cell Renal Cell Carcinoma and Suspected Recurrent Renal Clear Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 1 site in China.
Trial summary
The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma, Suspected Recurrent Renal Clear Cell Carcinoma, Recurrent Renal Cell Cancer
- What is being tested?
- 89Zr-Girentuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2023to 27 Nov 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed written informed consent
- Chinese male or female≥18 years old.
- Have an indeterminate renal mass, suspected renal cell carcinoma, or previously diagnosed ccRCC, suspected recurrence on the pre-screening imaging from Day -90 to Day -1
- Negative serum pregnancy test for female subjects of childbearing potential at screening. Confirmed negative urine pregnancy test within 24 hours prior to administration of investigational product.
- Expected survival ≥ 6 months.
- Agree to follow appropriate and highly effective contraception method for at least 35 days after the administration of 89Zr-TLX250.
Who cannot join
- Renal mass is known to be a metastasis of another primary tumor.
- Have other malignancies that require treatment.
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
- Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or such therapy resulted in a persistent adverse event (> Grade 1) (per National Cancer Institute-Common Toxicity Criteria version 5.0 [NCICTCAE v5.0]).
- Exposure to murine or chimeric antibodies within the last 5 years.
- Prior use of radionuclides with an interval of less than 10 halflives.
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- Exposure to any investigational diagnostic or therapeutic agent within the first 4 weeks or 5 half-lives (whichever is longer) of the planned administration of 89Zr-TLX250.
- Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m².
- Uncontrolled psychiatric disorders.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to girentuximab or DFO (deferoxamine).
- Have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease) that, in the opinion of the investigator, may interfere with the purpose of the study or subject safety or compliance.
- Vulnerable population (e.g., being in detention).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma
- Conditions
- Clear Cell Renal Cell Carcinoma, Suspected Recurrent Renal Clear Cell Carcinoma, Recurrent Renal Cell Cancer
- Being tested
- 89Zr-Girentuximab
- Keywords
- indeterminate renal masses, Suspected Recurrent Renal Clear Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-GirentuximabDrug
Also called 89Zr-DFO-girentuximab, 89Zr-TLX250, TLX250CDx
A single administration of 37 MBq (±10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, followed by whole body PET/CT scans were performed at 0.5h, 4h, 24h, 72 hours and 7±1 days post administration.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-girentuximab | Experimental | A single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab Receives: Drug: 89Zr-Girentuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameter Physical Examination
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.
Measured: 9 days
Safety parameter Vital Signs
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs
Measured: 9 days
Safety parameter Laboratory examinations
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.
Measured: 9 days
Safety parameter concomitant medications
Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.
Measured: 9 days
Safety parameter ECG
Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT Interval)
Measured: 9 days
Secondary outcomes (3)
Whole blood radioactivity PK parameters
This outcome will be measured by analysing the radioactivity present in the blood at baseline (pre-dose), 0.5h, 1h, 2h, 4h, 24h, 72h and Day 5+/-1 day. Assessments include: Cmax (maximum concentration)
Measured: 6 days
Radiation dosimetry
whole body PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection, using low dose CT without contrast agent. Normalized Absorbed Dose = Absorbed Dose/ Administered Dose
Measured: 8 days
Tumour dosimetry
Normalised whole body effective radiation dose (mSv/MBq)
Measured: Whole body PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start26 Jun 2023
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Cell Renal Cell CarcinomaStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grand Pharmaceutical (China) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhi Yang, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861778
- Sponsor's protocol ID
- TLX250CDx-CP-001
- Acronym
- ZIRDOSE-CP
- Status last verified
- Dec 2023
- First submitted
- 5 Apr 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu C, Ji Y, Wu X, Cerqueira B, Cade D, Du P, Yang Z. Evaluation of [89Zr]Zr-girentuximab PET imaging of clear cell renal cell carcinoma in chinese patients: a Phase 1 clinical study (ZIRDOSE-CP). EJNMMI Res. 2025 Dec 24;16(1):1. doi: 10.1186/s13550-025-01332-5.
PubMed 41444455
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05861778
- Acronym / sponsor ID
- ZIRDOSE-CP / TLX250CDx-CP-001
- Conditions
- Clear Cell Renal Cell Carcinoma, Suspected Recurrent Renal Clear Cell Carcinoma, Recurrent Renal Cell Cancer
- Keywords
- indeterminate renal masses, Suspected Recurrent Renal Clear Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Grand Pharmaceutical (China) Co., Ltd.
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 17 May 2023 (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.
The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-girentuximab | Experimental | Drug: 89Zr-GirentuximabA single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily signed written informed consent
- Chinese male or female≥18 years old.
- Have an indeterminate renal mass, suspected renal cell carcinoma, or previously diagnosed ccRCC, suspected recurrence on the pre-screening imaging from Day -90 to Day -1
- Negative serum pregnancy test for female subjects of childbearing potential at screening. Confirmed negative urine pregnancy test within 24 hours prior to administration of investigational product.
- Expected survival ≥ 6 months.
Key exclusion criteria (13 listed)
- Renal mass is known to be a metastasis of another primary tumor.
- Have other malignancies that require treatment.
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
- Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or such therapy resulted in a persistent adverse event (> Grade 1) (per National Cancer Institute-Common Toxicity Criteria version 5.0 [NCICTCAE v5.0]).
- Exposure to murine or chimeric antibodies within the last 5 years.
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-GirentuximabAlso: 89Zr-DFO-girentuximab, 89Zr-TLX250, TLX250CDxA single administration of 37 MBq (±10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, followed by whole body PET/CT scans were performed at 0.5h, 4h, 24h, 72 hours and 7±1 days post administration. | Drug | 89Zr-girentuximab |
Primary outcome
Safety parameter Physical Examination
Time frame: 9 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.
Safety parameter Vital Signs
Time frame: 9 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs
Safety parameter Laboratory examinations
Time frame: 9 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.
Safety parameter concomitant medications
Time frame: 9 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.
Safety parameter ECG
Time frame: 9 days
Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT Interval)
3 secondary outcomes
Whole blood radioactivity PK parameters
Time frame: 6 days
Radiation dosimetry
Time frame: 8 days
Tumour dosimetry
Time frame: Whole body PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 41444455Liu C, Ji Y, Wu X, Cerqueira B, Cade D, Du P, Yang Z. Evaluation of [89Zr]Zr-girentuximab PET imaging of clear cell renal cell carcinoma in chinese patients: a Phase 1 clinical study (ZIRDOSE-CP). EJNMMI Res. 2025 Dec 24;16(1):1. doi: 10.1186/s13550-025-01332-5.
- Individual participant dataSharing planned: No
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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.
Zhi Yang principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-Girentuximab in people with Clear Cell Renal Cell Carcinoma and Suspected Recurrent Renal Clear Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 1 site in China.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety parameter Physical Examination (time frame: 9 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861778, which also lists 1 linked publication.
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 11 Dec 2023.