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

NCT03849118 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 89Zr-TLX250-003
• Study Type: interventional
• Target: 300
• Locations: 8 countries
• Sites: 31

Brief Summary

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

clear cell renal cell carcinoma; PET/CT imaging; 89Zr-girentuximab

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of Qualitative Assessment of PET/CT Imaging With 89Zr-TLX250 to Noninvasively Detect ccRCC in Patients With Indeterminate Renal Masses, Using Histology as Standard of Truth.

  This outcome was evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This was compared against the histological determination of the lesion type following resection of the lesion

  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.

Study Arms (1)

89Zr-girentuximab

EXPERIMENTAL

A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration.

Diagnostic Test: 89Zr-girentuximab

Interventions

89Zr-girentuximab DIAGNOSTIC_TEST

Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.

Also known as: 89Zr-TLX250, 89Zr-DFO-TFP-girentuximab (GTX)

89Zr-girentuximab

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
• Male or female ≥18 years of age
• Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC
• Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
• Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
• for patients included in France only, verification and confirmation of their affiliation with a social security
• Sufficient life expectancy to justify nephrectomy
• Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration

You may not qualify if:

• Bioptic procedure (rather than a partial or total nephrectomy) 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
• Chemotherapy, radiotherapy 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 administration of 89 Zr-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 within the safety of compliance of the subjects 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 30 days from the date of planned administration of 89Zr-TLX250
• Women who are pregnant or breastfeeding
• Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
• Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2
• Vulnerable patients (e.g being in detention)

Sponsors & Collaborators

• Telix Pharmaceuticals (Innovations) Pty Limited: lead

Study Sites (31)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of California, Los Angeles Campus,

Los Angeles, California, 90095, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

Advanced Molecular Imaging & Therapy, LLC

Glen Burnie, Maryland, 21061, United States

Location

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, 48201, United States

Location

Washington University St Louis

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

SEATTLE CANCER CARE ALLIANCE, University of Washington

Seattle, Washington, 98109, United States

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Victorian Comprehensive Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Cabrini Hospital

Melbourne, Victoria, Australia

Location

Institute Jules Bordet

Brussels, 1000, Belgium

Location

University Hospital Leuven (UZ Leuven)

Leuven, 3000, Belgium

Location

Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM )

Montreal, Quebec, H2X0C1, Canada

Location

Jewish General Hopsital

Montreal, Quebec, H3T 1E2, Canada

Location

CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec

Québec, G1R2J6, Canada

Location

CHU de Bordeaux, Groupe hospitalier Pellegrin

Bordeaux, 33076, France

Location

CHRU de Nancy, Hopitaux de Brabois

Nancy, 54500, France

Location

Nantes University Hospital Hotel-Dieu

Nantes, 44000, France

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Radboud University Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Ankara University Medical Faculty Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine

Ankara, 06230, Turkey (Türkiye)

Location

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

• Chowdhury A, Morgat C, Bailly C, Sunderland J, Graves SA, Scott AM, Baker S, Holman BF. Radiation protection considerations with [89Zr]Zr-girentuximab PET and surgery. EJNMMI Res. 2025 May 23;15(1):59. doi: 10.1186/s13550-025-01247-1.

  PMID: 40408016 DERIVED

• Shuch B, Pantuck AJ, Bernhard JC, Morris MA, Master V, Scott AM, van Praet C, Bailly C, Onal B, Aksoy T, Merkx R, Schuster DM, Lee ST, Pandit-Taskar N, Fan AC, Allman P, Schmidt K, Tauchmanova L, Wheatcroft M, Behrenbruch C, Hayward CRW, Mulders P. [89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 Oct;25(10):1277-1287. doi: 10.1016/S1470-2045(24)00402-9. Epub 2024 Sep 10.

  PMID: 39270701 DERIVED

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

Results Point of Contact

• Title: Dr. Kavita Vadali, Sr. Clinical Project Manager
• Organization: Telix Pharmaceuticals (Innovations) Pty Ltd

kavita.vadali@telixpharma.com

+1 919-924-8887

Study Officials

• Howard Gurney, MD

  Macquarie University Hospital

  PRINCIPAL INVESTIGATOR

• Francoise Brodere, MD

  University Hospital ICO, Nantes, France

  PRINCIPAL INVESTIGATOR

• Peter Mulders, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Marcel Stokkel, MD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

• Declan Murphy, MD

  Victorian Comprehensive Cancer Centre

  PRINCIPAL INVESTIGATOR

• Andrew Scott, MD

  Olivia Newton John Cancer Research Center, Austin Hospital

  PRINCIPAL INVESTIGATOR

• Simon Wood, MD

  Princess Alexander Hospital

  PRINCIPAL INVESTIGATOR

• Mark Frydenberg, MD

  Cabrini Hospital

  PRINCIPAL INVESTIGATOR

• David Chan

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

• Jean-Christophe Bernhard, MD

  CHU de Bordeaux, Groupe Hospitalier Pellegrin

  PRINCIPAL INVESTIGATOR

• Pierre Olivier, MD

  CHRU de Nancy - Hôpitaux de Brabois

  PRINCIPAL INVESTIGATOR

• Linda Heijmen, MD

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

• Martin Geert Steffens, MD

  Isala

  PRINCIPAL INVESTIGATOR

• Karolien Goffin, MD

  Universitair Ziekenhuis Leuven

  PRINCIPAL INVESTIGATOR

• Carlos Artigas Guix, MD

  Instutit Jules Bordet

  PRINCIPAL INVESTIGATOR

• Nicolas Lumen, MD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Sumer Baltaci, MD

  Ankara University

  PRINCIPAL INVESTIGATOR

• Bulent Akdogan, MD

  Ankara Hacettepe University

  PRINCIPAL INVESTIGATOR

• Bulent Onal, MD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Tamer Aksoy, MD

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: diagnostic, confirmatory, prospective, multi-centre

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 21, 2019
• Study Start: August 15, 2019
• Primary Completion: October 20, 2022
• Study Completion: November 7, 2022
• Last Updated: May 17, 2024
• Results First Posted: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7); FR (3); GB (1); TU (4); NL (2); US (9); BE (2); CA (3)