89Zr-TLX250 for imaging clear cell kidney cancer

A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)

This study is testing a new imaging agent called 89Zr-TLX250 to see if it can help find clear cell kidney cancer in adults who have uncertain kidney masses before they have surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited (Industry-sponsored)
• Drugs / interventions: girentuximab, Chemotherapy, immunotherapy
• Locations: 8 sites (Beijing and 7 other locations)
• Trial ID: NCT06750419 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the safety and effectiveness of 89Zr-TLX250 PET/CT imaging in detecting clear cell renal cell carcinoma (ccRCC) in adult patients with indeterminate renal masses. Conducted in multiple centers across mainland China, the study aims to confirm the sensitivity and specificity of this imaging agent prior to nephrectomy. Participants will receive a single dose of 89Zr-TLX250 and undergo imaging 5±2 days later, followed by surgery within 90 days. The study seeks to recruit approximately 82 patients to ensure robust data collection.

Who should consider this trial

Good fit: Ideal candidates are adult patients in mainland China with a single indeterminate renal mass scheduled for nephrectomy.

Not a fit: Patients who are only undergoing biopsy procedures for diagnosis will not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging technique could provide a non-invasive method for accurately diagnosing clear cell renal cell carcinoma, potentially improving patient outcomes.

How similar studies have performed: Previous studies have shown promise with similar imaging approaches, but this specific application is part of a confirmatory phase.

Eligibility criteria

Inclusion Criteria:

1. Written and voluntarily given informed consent.
2. Mainland Chinese male or female, aged ≥ 18 years.
3. Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performed before any screening procedure.
4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.
5. Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
6. Sufficient life expectancy to justify nephrectomy.
7. Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.

Exclusion Criteria:

1. A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM.
2. Renal mass known to be a metastasis of another primary tumour.
3. Active non-renal malignancy requiring therapy during the time frame of the study participation.
4. Multiple unilateral or bilateral IRM.
5. Chemotherapy, radiotherapy, targeted therapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr -TLX250 or continuing adverse effects (\> grade 1) from such therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
6. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
7. Exposure to murine or chimeric antibodies within the last 5 years.
8. Previous administration of any radionuclide within 10 half-lives of the same.
9. 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 study subject, as judged by the investigator.
10. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
11. Exposure to any experimental diagnostic or therapeutic drug within 4 weeks or 5 half-lives (whichever is longer) from the date of planned administration of 89Zr-TLX250.
12. Women who are pregnant or breastfeeding.
13. Known hypersensitivity to girentuximab or desferoxamine (DFO).
14. Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m².
15. Vulnerable patients (e.g., being in detention).

Where this trial is running

Beijing and 7 other locations

• Beijing Cancer Hospital — Beijing, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, China (Not_yet_recruiting)
• Union Hospital Tongji Medical College Huazhong University Of Science And Technology — Hubei, China (Not_yet_recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, China (Not_yet_recruiting)
• Tianjin Cancer Hospital Airport Hospital — Tianjin, China (Not_yet_recruiting)
• Affiliated Hospital Of Jiangnan University — Wuxi, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Lily Nahidi

Conditions Clear Cell Renal Cell Carcinoma; 89Zr-DFO-girentuximab; 89Zr-girentuximab; 89Zr-DFO-TFP-GTX; Indeterminate Renal Mass; ZIRCON-CP study; 89Zirconium-labelled girentuximab; 89Zr-TLX250