89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
ConditionClear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTelix Pharmaceuticals (Innovations) Pty Limited
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written and voluntarily given informed consent.
Mainland Chinese male or female, aged ≥ 18 years.
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.
Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.
Disqualifiers
A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM.
Renal mass known to be a metastasis of another primary tumour.
Active non-renal malignancy requiring therapy during the time frame of the study participation.
Multiple unilateral or bilateral IRM.
Trial design
Design model
Single group
Treatments tested in this trial
89Zr-TLX250 PET/CT
Drug89Zr-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.
Treatment groups
82 Participants
are divided into 1 treatment groupGroup A: Experimental arm receiving the IPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 truthSecondary outcomes
1
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).2
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).3
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).4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov