A Phase 3 interventional study of 89Zr-TLX250 PET/CT in Clear Cell Renal Cell Carcinoma, sponsored by Telix Pharmaceuticals (Innovations) Pty Limited. Recruiting at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Telix Pharmaceuticals (Innovations) Pty Limited · Phase 3, Interventional, and Diagnostic
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)
This will be a confirmatory, prospective, open-label, single-arm, multi-centre study in a Chinese patient population. The study is designed to evaluate the safety, tolerability, sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect Clear Cell Renal Cell Carcinoma (ccRCC). The multi-centre study will be conducted in mainland China in adult patients with Indeterminate Renal Masses (IRM), who are scheduled for partial or total nephrectomy as part of their standard of care.
Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging.
The study involves a single administration of 37 MBq (±10%) of 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, in mainland Chinese participants (ZIRCON-CP). This is consistent with the confirmatory, prospective, multinational clinical trial ZIRCON (ClinicalTrials.gov ID: NCT03849118). This study consists of seven visits. Imaging will then be conducted 5±2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.
On Day 5±2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator.
Image data analyses will be performed by a central imaging vendor.
For participants who were nephrectomised within 28 days post administration, the final study visit will be conducted on Day 42 (±7 days). For participants with nephrectomy between 28 and 90 days post administration, the final study visit will be performed 35 days (±7 days) after surgery.
Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or Magnetic Resonance Imaging [MRI]), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.
The duration of this study is expected to be about 12 months, with a follow-up of 4 months. The study duration for a single participant will be approximately between 4 - 6 months.
No interim analysis is planned for this study.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 82 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Exclusion Criteria:
Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging. Following pre-screen morphological imaging to confirm evidence of IRM (to occur within 90 days of study enrolment), participants will attend a screening visit within 30 days of study enrolment, at which time baseline examinations will be undertaken. On Day 0, all successfully screened participants will undergo a slow IV administration of 89Zr- TLX250, at the nuclear medicine service of the respective study site. For all subjects, a PET/CT scan of the abdomen will occur on visit Day 5 (±2 days post administration \[p.a.\]) with nephrectomy to be performed any time after the PET/CT imaging visit, but no later than 90 days p.a. 89Zr-TLX250.
Drug: 89Zr-TLX250 PET/CT
89Zr-TLX250, is a chimeric monoclonal antibody (INN name: girentuximab) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting radiometal zirconium- 89. Girentuximab has a CAS number of 916138-87-9. The chemical formula, without the 89Zr and the desferrioxamine, is C6460H1006N1718O2018S48 with a molecular mass of 146.5 kg/mol. 89Zr-TLX250 is formulated as a solution for IV administration in glass vials at the nominal dosage strength of 37 MBq (±10%) for single IV use. The mass dose of 89Zr-TLX250 to be used in this Phase 3 study will be 10 mg, labelled with 37 MBq (±10%) 89Zr per dose.
Also known as: 89Zr-DFO-girentuximab, 89Zr-girentuximab, 89Zr-DFO-TFP-GTX, 89Zirconium-labelled girentuximab
To evaluate the sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth
Evaluating this outcome involved using a PET/CT machine on all patients to determine the uptake of the Zr89 radiotracer within the renal lesion, which was then compared to the histological determination of the lesion type following resection
Time frame: From Visit 4 till end of study. Diagnostic PET/CT scan on Day 5±2 days post 89Zr-TLX250 administration. Histological confirmation of the material from nephrectomy conducted within 90 days post 89Zr-TLX250 administration served as standard of truth
To determine the 89Zr-TLX250's test performance
Determine the Standardized Uptake Value (SUV) in detecting ccRCC from non-ccRCC in the kidney in the Chinese patient population.
Time frame: Day of Imaging (Day 5±2 post- IP administration).
To determine the 89Zr-TLX250's test performance
Determine the predictive values (%) of 89Zr-TLX250 PET/CT in detecting ccRCC from non-ccRCC in the kidney in the Chinese patient population.
Time frame: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
To determine the 89Zr-TLX250's test performance
Evaluate the diagnostic accuracy (%) of 89Zr-TLX250 PET/CT in distinguishing ccRCC from non-ccRCC in the kidney in the Chinese patient population.
Time frame: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
To assess the safety and tolerability of 89Zr-TLX250
Number of AEs, incidence of anti-drug antibody detection following use of the study drug in Chinese patients with IRM
Time frame: Day of IP administration (Day 0), Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28-90 days post-IP administration)
To evaluate the impact of 89Zr-TLX250 PET/CT on clinical decision-making as a diagnostic tool
Proportion of participants with changes in management plans based on PET/CT scan findings versus conventional imaging following the use of 89Zr-TLX250
Time frame: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
Plan to share: No — IPD will not be shared with other researchers as it is in line with ICH-GCP guidelines, which emphasise the protection of participant confidentiality and the integrity of the study data. Additionally, sharing of IPD is not planned to ensure compliance with regulatory requirements and to maintain the proprietary nature of the data.
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Telix Pharmaceuticals (Innovations) Pty Limited