89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study

NCT06750419 | Recruiting Phase 3 DMC

• 1 other identifier: TLX250CDx-CP-002
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 8

Brief Summary

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)

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

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

Outcome Measures

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

  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

Secondary Outcomes (5)

• To determine the 89Zr-TLX250's test performance

  Day of Imaging (Day 5±2 post- IP administration).

• To determine the 89Zr-TLX250's test performance

  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

  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

  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

  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).

Study Arms (1)

Experimental arm receiving the IP

EXPERIMENTAL

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

Interventions

89Zr-TLX250 PET/CT DRUG

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

Experimental arm receiving the IP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Sufficient life expectancy to justify nephrectomy.
• Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.

You may not qualify if:

• 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.
• 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).
• Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
• Exposure to murine or chimeric antibodies within the last 5 years.
• Previous administration of any radionuclide within 10 half-lives of the same.
• 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.
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• 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.
• Women who are pregnant or breastfeeding.
• Known hypersensitivity to girentuximab or desferoxamine (DFO).
• Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m².
• Vulnerable patients (e.g., being in detention).

Sponsors & Collaborators

• Telix Pharmaceuticals (Innovations) Pty Limited: lead

Study Sites (8)

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

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Related Links

• IPD registration in Chinadrugtrials as per Chinese requirements

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Lily Nahidi

CONTACT

+61 3909 33871; lily.nahidi@telixpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 27, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)