A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)

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)

Start Date06 Nov 2024

Sponsor / Collaborator

Telix Pharmaceuticals Ltd.

NCT06447103

/ RecruitingPhase 2IIT

89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery

This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.

Start Date06 Aug 2024

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

NCT05861778

/ CompletedPhase 1

An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma

The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma

Start Date26 Jun 2023

Sponsor / Collaborator

Telix International Pty Ltd

[+1]

100 Clinical Results associated with Zirconium (89Zr) girentuximabum senvedoxamum

100 Translational Medicine associated with Zirconium (89Zr) girentuximabum senvedoxamum

100 Patents (Medical) associated with Zirconium (89Zr) girentuximabum senvedoxamum

Literatures (Medical) associated with Zirconium (89Zr) girentuximabum senvedoxamum

01 Feb 2025·Expert Review of Anticancer Therapy

Girentuximab imaging in renal cancer: diamond in the rough or just ZIRCON?

Review

Author: Urso, Luca ; Evangelista, Laura ; D’Angelillo, Rolando Maria ; Filippi, Luca

Small renal masses (SRM), especially those under 7 cm pose significant diagnostic challenges when using conventional imaging (CT/MRI). PET/CT with [⁸⁹Zr]Zr-girentuximab offers a promising alternative in this setting by enabling molecular-level imaging. The ZIRCON trial, a phase 3 multicenter study, evaluated the diagnostic accuracy of [⁸⁹Zr]Zr-girentuximab PET/CT in detecting clear cell renal cell carcinoma (ccRCC) in SRM. A total of 300 patients with indeterminate renal masses received a single intravenous dose of [⁸⁹Zr]Zr-girentuximab, followed by PET/CT imaging 5 days post-injection. Generally, sensitivity and specificity for ccRCC detection were 85.5% and 87.0%, respectively. However, smaller masses (maximum diameter: ≤4 cm) demonstrated strong diagnostic performance, with mean sensitivity and specificity of 85% and 89.5%, respectively. PET positivity was observed exclusively in malignant lesions. Nevertheless, both benign and malignant non-ccRCC tumors are 'cold' at [⁸⁹Zr]Zr-girentuximab, thus differential diagnosis remains an unresolved issue. Despite its strengths, the trial highlights limitations: restricted imaging scope to the abdomen, lack of a cost-effectiveness analysis, concerns over radiation exposure given zirconium-89's 78.4-h half-life, and the daily scheduling of the examination. Only further studies and time will reveal whether the ZIRCON trial's findings will shine like a diamond or remain akin to zircon - brilliant but constrained in value.

01 Nov 2024·Med

[89Zr]Zr-girentuximab PET-CT imaging to diagnose, characterize, and differentiate clear-cell renal cell carcinoma

Article

Author: Agarwal, Neeraj ; Hage Chehade, Chadi ; Gebrael, Georges

In the phase 3 ZIRCON trial, [⁸⁹Zr]Zr-girentuximab positron emission tomography-computed tomography (PET-CT) detected the presence of clear-cell renal cell carcinoma (ccRCC) with a sensitivity of 86% and a specificity of 87% in patients with an indeterminate renal mass undergoing nephrectomy.¹ This imaging technique could be a promising tool that could revolutionize the management of small renal masses (SRMs) and ccRCC.

01 Oct 2024·LANCET ONCOLOGY

[89Zr]Zr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial

Article

Author: Scott, Andrew M ; Hayward, Colin R W ; Pandit-Taskar, Neeta ; Merkx, Robin ; Lee, Sze Ting ; Önal, Bülent ; Tauchmanova, Libuse ; van Praet, Charles ; Schmidt, Karl ; Behrenbruch, Christian ; Pantuck, Allan J ; Schuster, David M ; Allman, Phillip ; Mulders, Peter ; Bailly, Clement ; Aksoy, Tamer ; Master, Viraj ; Shuch, Brian ; Wheatcroft, Michael ; Fan, Alice C ; Morris, Michael A ; Bernhard, Jean-Christophe

BACKGROUND:

With limitations of conventional imaging and biopsy, accurate, non-invasive techniques to detect clear-cell renal cell carcinoma in patients with renal masses remain an unmet need. ⁸⁹Zr-labelled monoclonal antibody ([⁸⁹Zr]Zr-girentuximab) has high affinity for carbonic anhydrase 9, a tumour antigen highly expressed in clear-cell renal cell carcinoma. We aimed to evaluate [⁸⁹Zr]Zr-girentuximab PET-CT imaging for detection and characterisation of clear-cell renal cell carcinoma.

METHODS:

ZIRCON was a prospective, open-label, multicentre, phase 3 trial conducted at 36 research hospitals and practices across nine countries (the USA, Australia, Canada, the UK, Türkiye, Belgium, the Netherlands, Spain, and France). Patients aged 18 years or older with an indeterminate renal mass 7 cm or smaller (cT1) suspicious for clear-cell renal cell carcinoma and scheduled for nephrectomy received a single dose of [⁸⁹Zr]Zr-girentuximab (37 MBq ±10%; 10 mg girentuximab) intravenously followed by abdominal PET-CT imaging 5 days (±2 days) later. Surgery was performed no later than 90 days after administration of [⁸⁹Zr]Zr-girentuximab. Blinded central review, conducted by three independent readers, determined the histology from surgical samples. The coprimary endpoints, determined for each individual reader, were the sensitivity and specificity of [⁸⁹Zr]Zr-girentuximab PET-CT imaging to detect clear-cell renal cell carcinoma, with histopathological confirmation as standard of truth. Analyses were on the full analysis set of patients, defined as patients who had evaluable PET-CT imaging and a confirmed histopathological diagnosis. The trial is registered with ClinicalTrials.gov, NCT03849118, and EUDRA Clinical Trials Register, 2018-002773-21, and is closed to enrolment.

FINDINGS:

Between Aug 14, 2019, and July 8, 2022, 371 patients were screened for eligibility, 332 of whom were enrolled. 300 patients received [⁸⁹Zr]Zr-girentuximab (214 [71%] male and 86 [29%] female). 284 (95%) evaluable patients were included in the primary analysis. The mean sensitivity was 85·5% (95% CI 81·5-89·6) and mean specificity was 87·0% (81·0-93·1). No safety signals were observed. Most adverse events were not or were unlikely to be related to [⁸⁹Zr]Zr-girentuximab, with most (193 [74%] of 261 events) occurring during or after surgery. The most common grade 3 or worse adverse events were post-procedural haemorrhage (in six [2%] of 261 patients), urinary retention (three [1%]), and hypertension (three [1%]). In 25 (8%) of 300 patients, 52 serious adverse events were reported, of which 51 (98%) occurred after surgery. There were no treatment-related deaths.

INTERPRETATION:

Our results suggest that [⁸⁹Zr]Zr-girentuximab PET-CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of clear-cell renal cell carcinoma, which has the potential to be practice changing.

FUNDING:

Telix Pharmaceuticals.

News (Medical) associated with Zirconium (89Zr) girentuximabum senvedoxamum

14 Mar 2025

·endpts.com

Altimmune to put its incretin into addiction trials; Tarsus aims to raise $125M

Plus, news about Heidelberg, Accropeutics, Allarity Therapeutics, Cadrenal and Inovio: Altimmune to test its incretin in addiction : Following the path set by Novo Nordisk last week , Altimmune said Thursday at its R&D Day that it plans to begin trials of its injectable GLP-1/glucagon agonist pemvidutide in alcohol use disorder as well as alcoholic liver disease. Stifel analysts wrote in a note on Thursday that Altimmune has animal data that suggest pemvidutide could reduce daily alcohol intake by around half. They also cautioned that additional data would be needed to validate the hypothesis. — Elizabeth Cairns Tarsus Pharmaceuticals’ expected $125 million stock sale: The drugmaker said the funds from the public offering will be used to support the US commercialization of Xdemvy, eye drops for irritation caused by tiny mites. Tarsus also said the funds will be used to advance its experimental ocular rosacea and lyme disease drugs. — Lei Lei Wu Heidelberg amends royalty deal: The company signed an agreement with HealthCare Royalty a year ago to provide royalties to Zircaix, or TLX250-CDx, an imaging agent for some kidney cancers. While the total value of the milestones remains the same at $90 million, the companies changed the deal so that Heidelberg will receive $20 million immediately rather than get $15 million as a sales milestone. They also reduced the FDA approval milestone to $70 million from $75 million. (That milestone will be further reduced if approval comes after 2025.) Heidelberg licensed the drug to Telix in 2017, and a rolling FDA submission was initiated in 2023. — Max Gelman Accropeutics raises $12M to fund IBD asset : The Series B-plus round was led by Shenzhen Capital Group and is set to extend the biotech’s cash runway into the second half of next year. The proceeds will be used for the ongoing Phase 1b trial of Accropeutics’ RIPK2 inhibitor, known as AC-101, in ulcerative colitis. Accropeutics also has a mid-stage TYK2/JAK1 inhibitor in development for psoriasis and a RIPK1 inhibitor for graft-versus-host disease. — Elizabeth Cairns Allarity Therapeutics settles with SEC: The company will pay $2.5 million to the Securities and Exchange Commission after the regulator alleged Allarity executives concealed from investors that the FDA had recommended against approving dovitinib, an experimental cancer therapy. The company did not admit or deny the allegations. — Jaimy Lee Cadrenal is still seeking a partner for tecarfarin: It wants help advancing the oral vitamin K antagonist into a pivotal trial for patients with left ventricular assist devices and other rare cardiovascular conditions. — Jaimy Lee Inovio’s DNA therapy is durable in early trial : The company said Thursday that a Phase 1 trial proves the concept of its so-called DMAbs. The DNA plasmids encoding antibodies derived from Evusheld, AstraZeneca’s Covid-19 prophylactic, were given to patients and were translated into the proteins by the patient’s own cells. All subjects who reached week 72 had biologically relevant levels of the antibodies, according to Inovio, and the expressed DMAbs bound to the SARS-CoV-2 spike protein confirmed functional activity. However, the company did not say whether the approach prevented infections . — Elizabeth Cairns

Phase 1Clinical Result

13 Mar 2025

·heidelberg-pharma.com

PR: Heidelberg Pharma Amends Royalty Financing with HealthCare Royalty

HealthCare Royalty and Heidelberg Pharma amend royalty financing agreement to provide for USD 20 million payment Heidelberg Pharma extends cash runway into 2027 Ladenburg, Germany, 13 March 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed an amendment to the royalty financing agreement entered into in March 2024. The March 2024 royalty financing agreement and current amendment cover the partial monetization of Heidelberg Pharma’s future royalties on the worldwide sales of TLX250-CDx, a radiopharmaceutical Positron Emission Tomography (PET) imaging agent for the diagnosis and characterization of clear cell renal cancer. An upfront payment of USD 25 million was already made to Heidelberg Pharma in March 2024. Key terms of the amended agreement between Heidelberg Pharma and HCRx are as follows: Heidelberg Pharma will receive a payment of USD 20 million upon signature. The USD 15 million sales-based milestone for year 2025 is eliminated. The originally agreed USD 75 million payment upon FDA approval of TLX250-CDx will be reduced to USD 70 million, with further reductions if FDA approval occurs after the end of 2025. The second tier of the two-tier escalating cap on cumulative royalties sold to HCRx has increased. When the escalating cap has been reached, royalty payments will return to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereof. Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “The amendment with HCRx provides us with non-dilutive financing and will significantly increase our cash reach. Due to the delay in FDA approval of TLX250-CDx, the agreed sales-based milestone payment would have been difficult to achieve and has now instead been converted into another payment. We are very pleased that our development and commercialization partner Telix has received positive feedback from the FDA on its Biologics License Application and has been granted priority review. We expect an approval decision and the next significant milestone payment by the end of August.” Based on the agreement with HCRx and expected incremental payments of USD 90 million to Heidelberg Pharma, the company anticipates an extended cash runway into 2027. About TLX250-CDx TLX250-CDx is a radiolabeled form of the antibody girentuximab which binds to the tumor-specific antigen CAIX on clear cell renal cell carcinomas. TLX250-CDx also has potential as a PET diagnostic imaging agent for other tumor types. Heidelberg Pharma developed the antibody up to a first completed Phase III clinical trial prior to licensing it to Telix Pharmaceuticals Limited (Telix), an Australian company based in Melbourne, Australia, in 2017. About Heidelberg Pharma Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells. Heidelberg Pharma uses several compounds and has built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. The goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors. Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology. The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com. ATAC® is a registered trademark of Heidelberg Pharma Research GmbH. ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH. About Healthcare Royalty HealthCare Royalty (HCRx) is a leading royalty acquisition company focused on commercial or near-commercial biopharmaceutical products. With offices in Stamford, Conn., San Francisco, Boston, London and Miami, HCRx has invested $5+ billion in over 90 biopharmaceutical products since inception. For more information, visit https://www.hcrx.com. HEALTHCARE ROYALTY® and HCRx® are registered trademarks of HealthCare Royalty Management, LLC.

Phase 3ADCAcquisition

12 Mar 2025

·heidelberg-pharma.com

AH: Heidelberg Pharma Amends Royalty Financing with HealthCare Royalty

ADCLicense out/inPhase 3Phase 1

100 Deals associated with Zirconium (89Zr) girentuximabum senvedoxamum

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal Cell Carcinoma	NDA/BLA	United States	Telix Pharmaceuticals Ltd.	18 Dec 2023
Transitional Cell Carcinoma	Phase 3	-	Heidelberg Pharma Research GmbH	30 May 2023
Kidney Neoplasms	Phase 3	-	Heidelberg Pharma AG	-
Clear Cell Sarcoma of Kidney	Phase 2	United States	Telix Pharmaceuticals Ltd.	06 Aug 2024
Bile Duct Neoplasms	Phase 2	United States	Telix Pharmaceuticals Ltd.	06 Jun 2023
Colorectal Cancer	Phase 2	United States	Telix Pharmaceuticals Ltd.	06 Jun 2023
Esophageal Carcinoma	Phase 2	United States	Telix Pharmaceuticals Ltd.	06 Jun 2023
Glioblastoma Multiforme	Phase 2	United States	Telix Pharmaceuticals Ltd.	06 Jun 2023
Hepatocellular Carcinoma	Phase 2	United States	Telix Pharmaceuticals Ltd.	06 Jun 2023
Nasopharyngeal Carcinoma	Phase 2	United States	Telix Pharmaceuticals Ltd.	06 Jun 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2024	Not Applicable	Radiation Injuries	-	89Zr-girentuximab	kpqmlebtha(fcgulijfez) = zxuhqwfheu fpczrtifot (tagfyafwio )	-	09 Jun 2024
NCT04758780 (OPALESCENCE, PRNewswire) Manual	Phase 2	Triple Negative Breast Cancer HER2 Negative \| PR Negative \| ER Negative	12	TLX250-CDx	xifusuhggv(jdbpevqxgt) = in the breast, skin, adrenal gland and brain was 100% qxafrkntrr (wcoykdgeys ) View more	Positive	06 Dec 2023
NCT03849118 (ZIRCON, ASCO_GU2023) Manual	Phase 3	Renal Cell Carcinoma	284	89Zr-DFO-girentuximab	xtvzqfmrdd(ibzvsrrvuj) = ukickndbld vkzhqzbudk (ssdonrzpfu, 80 - 90) Met View more	Positive	21 Feb 2023
NCT03849118 (ZIRCON, PRNewswire) Manual	Phase 3	Kidney Neoplasms	284	Girentuximab-Zr-89	cehtcstczr(uxqrrddjdh) = dvpqehzlce zvwerupruw (zurmcvozox ) View more	Positive	06 Nov 2022

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