Drugs / girentuximab
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04897763 | Dec 2021 → Aug 2022 | urinary bladder cancer | Institut Cancerologie de l'Ouest | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT00520533 | Feb 2008 → Jul 2011 | renal cell carcinoma | Ludwig Institute for Cancer Research | Terminated | No outcome recorded |
| Phase 1 | NCT00199888 | Jun 2005 → Mar 2006 | clear cell renal carcinoma | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00142415 | Feb 2005 → Jan 2011 | renal cell carcinoma | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1/2 | NCT00003102 | Nov 1998 → Apr 2000 | kidney cancer | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06447103 | Aug 2024 → Dec 2029 expected | clear cell renal carcinoma, sarcomatoid renal cell carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02883153 | Dec 2015 → Jun 2017 | renal cell carcinoma | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT01762592 | Dec 2017 → Dec 2018 | renal cell carcinoma | Heidelberg Pharma AG | Withdrawn | No outcome recorded |
| Phase 3 | NCT00606632 | Mar 2008 → Nov 2009 | renal cell carcinoma | Heidelberg Pharma AG | Completed | Met primary |
| Phase 3 | NCT00087022 | Jul 2004 → Oct 2012 | kidney cancer | Heidelberg Pharma AG | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT00602862 | Jul 2007 → Apr 2012 | clear cell renal carcinoma | Radboud University Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-05-05 | Telix Pharmaceuticals (Innovations) Pty Limited | Results New Publication Demonstrates TLX250-Px (Zircaix®) Potential in Diagnosing Kidney Cancers Beyond ccRCC telixpharma.com ↗
This analysis shows that when TLX250-Px PET/CT is positive, it is highly predictive of renal malignancy, including beyond ccRCC. |
| 2025-11-19 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ZIRCON-X Analysis: TLX250-CDx Impacts Clinical Decision Making for Almost Half of Patients with Indeterminate Renal Masses telixpharma.com ↗
The study found that 143 patients (48.6%) would have undergone a change in clinical management if imaged with TLX250-CDx, and over 20% of these patients (31 out of 143) could have potentially avoided invasive biopsy[5]. |
| 2024-12-29 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Files TLX250-CDx (Zircaix®) BLA for Kidney Cancer Imaging telixpharma.com ↗
Telix today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®[1], 89Zr- girentuximab) kidney cancer imaging[2]. |
| 2024-09-10 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ‘Highly Accurate’: Telix’s Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology telixpharma.com ↗
Authors conclude that TLX250-CDx “has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of ccRCC, which has the potential to be practice changing.” |
| 2023-12-18 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Submits Biologics License Application (BLA) for TLX250-CDx (Zircaix™) for Imaging of Kidney Cancer telixpharma.com ↗
Telix today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (Zircaix™,[1] 89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC). |
| 2023-12-06 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Positive Topline Results from Phase II OPALESCENCE Study of TLX250-CDx in Triple Negative Breast Cancer Presented at SABCS telixpharma.com ↗
Telix announces positive topline results from the Phase II OPALESCENCE investigator-initiated trial (IIT) of its carbonic anhydrase IX (CAIX)-targeting positron emission tomography (PET) imaging candidate, TLX250-CDx (89Zr-DFO-girentuximab), in patients with triple negative breast cancer (TNBC). |
| 2023-06-26 | Telix Pharmaceuticals (Innovations) Pty Limited | Results New ZIRCON Phase III Data Presented at SNMMI: Potential Utility of TLX250-CDx in Staging and Monitoring ccRCC telixpharma.com ↗
New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions. |
| 2023-06-22 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Telix to Showcase ZIRCON Phase III Kidney Cancer Imaging Data and Theranostic Pipeline Developments at SNMMI telixpharma.com ↗
89Zr-DFO-girentuximab PET/CT imaging can accurately detect clear cell renal cell carcinoma (ccRCC) primary and secondary lesions in patients with renal masses at conventional imaging, results from ZIRCON Phase III study |
| 2023-04-30 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ZIRCON Phase III Kidney Cancer Imaging Study Presented at AUA: New Data Confirms Efficacy in Masses 2cm or Smaller telixpharma.com ↗
Telix today announces additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118). |
| 2023-03-13 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Telix’s ZIRCON Phase III Kidney Cancer Imaging Study Presented in “Game Changing” Session at EAU telixpharma.com ↗
Telix today announces additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118). |
| 2023-02-19 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Detailed Results from Telix’s ZIRCON Phase III Kidney Cancer Imaging Study Presented at ASCO GU telixpharma.com ↗
Telix today announces detailed positive results from its completed pivotal Phase III ZIRCON trial (ClinicalTrials.gov Identifier: NCT03849118)1. |
| 2022-11-07 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma’s Partner Telix Reports Positive Data on the Pivotal ZIRCON Study heidelberg-pharma.com ↗
The study has also met the key secondary endpoint, achieving 85% sensitivity and 89% specificity in detecting ccRCC in tumors <4 cm (“T1a” classification), currently a significant clinical challenge in the diagnosis of ccRCC. |
| 2022-11-06 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Telix Announces Positive Topline Results of ZIRCON Phase III Kidney Cancer Imaging Study telixpharma.com ↗
Telix today announces highly positive top-line results from the pivotal Phase III ZIRCON study (Zirconium in Renal Cancer Oncology, NCT03849118) of its investigational renal (kidney) cancer positron emission tomography (PET) imaging agent, TLX250-CDx (89Zr-DFO-girentuximab). |
| 2022-09-28 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Chinese NMPA Approves Study of Telix Kidney Cancer Imaging Candidate telixpharma.com ↗
Chinese NMPA Approves Study of Telix Kidney Cancer Imaging Candidate |
| 2022-08-02 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory APAC Report: Regulatory Progress for Prostate and Kidney Cancer Imaging telixpharma.com ↗
An IND application has been submitted by Grand Pharma to the NMPA CDE (and accepted for review) |
| 2021-09-14 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Approves Phase II Kidney Cancer Therapy Study telixpharma.com ↗
Telix is pleased to announce that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) Application to undertake a clinical study of the Company’s investigational kidney cancer therapy, TLX250 (177Lu-DOTA-girentuximab). |
| 2021-04-21 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Japanese Renal Cancer Imaging Trial Meets Study Objectives telixpharma.com ↗
Telix announces the Company’s ZIRDAC-JP study of its renal cancer imaging product demonstrates safety and tolerability in Japanese patients. |
| 2019-08-30 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Cleared to Commence Renal Cancer Imaging Study in Japan telixpharma.com ↗
The Japanese Pharmaceutical and Medical Devices Agency (PMDA) has completed review of the proposed clinical trial and Telix is now permitted to proceed with the study. |
All press releases naming this drug 18 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Girentuximab | “The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the...” NCT04897763 ↗6“Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma.” PMID 22980441 ↗ Aug 2012 “PET/CT and contrast-enhanced CT (CECT) of the abdomen were performed 2 to 6 days after intravenous (124)I-girentuximab administration” PMID 23213092 ↗ Dec 2012 |
| Known as | 131I-cG250 | “Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250)” NCT00003102 ↗ |
| Known as | 89Zr-girentuximab | “89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients” NCT04897763 ↗ |
| Known as | 89Zr-TLX250 | “The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the...” NCT04897763 ↗ |
| Known as | cG250 | “OBJECTIVE: We determined the maximum tolerated dose (MTD) and potential therapeutic efficacy of multiple infusions of lutetium 177 ((177)Lu)-girentuximab (cG250) on various...” PMID 22980441 ↗ Aug 2012 |
| Known as | chimeric G250 | “The antibody we will use in this study is called chimeric G250 (cG250).” NCT00199888 ↗ |
| Known as | G250 | “Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250)” NCT00003102 ↗ |
| Known as | GmAb | “Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope).” NCT06447103 ↗ |
| Action | Inhibit | “One possible method of interfering with the function of G250 is to target G250 with an antibody known as cG250.” NCT00520533 ↗ |
| Modality | Monoclonal antibody | “cG250 is an IgG1 chimeric monoclonal antibody.” NCT00003102 ↗ |
| Route | Intravenous | “administered intravenously (IV) over 10 minutes.” NCT00003102 ↗ |
| Target | CA9 | “anti-carbonic anhydrase IX monoclonal antibody” PMID 22980441 ↗ Aug 2012 |