Delving into the Latest Updates on Iodine (124I) Girentuximab with Synapse

Overview

Basic Info

Drug Type

Radiolabeled antibody, Diagnostic radiopharmaceuticals

Synonyms

124-Iodine labeled WX-G250, 124-Iodine labeled monoclonal antibody G250, Girentuximab I-124

+ [7]

Target

CAIX

Mechanism

CAIX inhibitors(Carbonic anhydrase IX inhibitors), PET imaging(Positron-emission tomography enhancers)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Transitional Cell CarcinomaTriple Negative Breast Cancer

Inactive Indication

Kidney NeoplasmsRenal Cell Carcinoma

Originator Organization

Heidelberg Pharma AG

Active Organization

Telix Pharmaceuticals Ltd.Heidelberg Pharma Research GmbH

Inactive Organization

Wilex GmbH Im- u. Export von Investitions- und Verbrauchsgüter

Heidelberg Pharma AG

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure

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Gene Sequence

Sequence Code 143780L

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Sequence Code 143552H

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Usually, doctors monitor kidney cancer with CT scans to measure the size of tumors. Sometimes, even when a drug is working, it can take several months before the effects are seen on a regular CT scan. The purpose of this study is to see if a new kind of scan, called 124I-cG250 PET/CT, can determine response to sunitinib or pazopanib earlier than a regular CT scan.
Research has shown that certain proteins in the blood, called antibodies, can attach themselves to cancer cells without binding to normal cells. In this study, an antibody is used called chimeric G250 (cG250) that is attached to a radioactive isotope. The radioactive isotope in this study is Iodine-124 (124I). If cG250 has attached to tumors in the body, 124I shows up on the PET scan.

Start Date01 Apr 2012

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT00606632 / CompletedPhase 3

A Comparative Study of PET/CT Versus Diagnostic CT for the Detection of Clear Cell Renal Cell Carcinoma in Pre-surgical Patients With Renal Masses Using Iodine-124 Labeled Chimeric G250 (124I-cG250)

This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.

Start Date01 Mar 2008

Sponsor / Collaborator

Heidelberg Pharma AG

100 Clinical Results associated with Iodine (124I) Girentuximab

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100 Translational Medicine associated with Iodine (124I) Girentuximab

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100 Patents (Medical) associated with Iodine (124I) Girentuximab

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5

Literatures (Medical) associated with Iodine (124I) Girentuximab

01 Mar 2018·Current Opinion in UrologyQ4 · MEDICINE

The role of molecular imaging in the characterization of renal masses

Q4 · MEDICINE

Review

Author: Allaf, Mohamad E ; Gorin, Michael A ; Rowe, Steven P ; Meyer, Alexa R

PURPOSE OF REVIEWTo explore the role of molecular imaging in the characterization of renal masses.RECENT FINDINGSIncidentally detected renal masses exhibit variable malignant potential related to their underlying histology. Patients presenting with a renal mass should undergo individual risk stratification including characterization of their tumor histology. At the present time, anatomical imaging techniques are unable to reliably distinguish between the various renal tumor subtypes. Although renal mass biopsy is helpful in this regard, there are limitations of this procedure. Molecular imaging offers a noninvasive means of determining the histology of renal tumors. Imaging tests that have shown particular promise for this application include I-girentuximab PET/CT for diagnosing clear cell renal cell carcinoma and Tc-sestamibi SPECT/CT for diagnosing renal oncocytomas and hybrid oncocytic/chromophobe tumors.SUMMARYMolecular imaging offers a noninvasive means of determining the histology of renal tumors thereby aiding in the risk stratification of patients presenting with a renal mass. Future work aims to develop a molecular imaging test that employs dual radiotracers allowing for the more precise characterization of renal tumors in a convenient single radiologic study.

01 Jan 2015·Indian Journal of Urology

Management of urological malignancies: Has positron emission tomography/computed tomography made a difference?

Article

Author: Nirmal, Thampi John ; Kekre, Nitin S

Positron emission tomography/computed tomography (PET/CT) technology has been a significant, but expensive addition to the oncologist's armamentarium. The aim of this review was to determine the clinical utility of PET/CT in urological oncology, its impact on disease outcome and cost-effectiveness. We searched MedLine and peer reviewed journals for all relevant literature available online from the year 2000 until January 2014 regarding the use of PET/CT in the management of urological malignancies. (11)C-choline PET/CT has emerged as a powerful tool for assessment of biochemical relapse in prostate cancer. Use of novel radiotracers like (124)I-girentuximab has shown promise in the diagnosis of clear cell renal carcinoma. Fluorodeoxyglucose PET has a proven role in seminoma for the evaluation of postchemotherapy residual masses and has shown encouraging results when used for detection of metastasis in renal, bladder, and penile cancer. Introduction of novel radiotracers and advanced technology has led to a wider application of PET/CT in urological oncology. However, testicular seminoma aside, its impact on disease outcome and cost-effectiveness still needs to be established.

01 Jun 2014·Journal of Nuclear MedicineQ1 · MEDICINE

Optical Imaging of Renal Cell Carcinoma with Anti–Carbonic Anhydrase IX Monoclonal Antibody Girentuximab

Q1 · MEDICINE

Article

Author: Rijpkema, Mark ; Oyen, Wim J G ; Stillebroer, Alexander B ; Franssen, Gerben M ; Mulders, Peter F A ; Boerman, Otto C ; Oosterwijk, Egbert ; Muselaers, Constantijn H J

Near-infrared dye-tagged antibodies can be used for the sensitive detection of tumor tissue in vivo. Surgery for clear-cell renal cell carcinoma (ccRCC) might benefit from the use of optical imaging to facilitate the intraoperative detection of carbonic anhydrase IX (CAIX)-expressing tumor lesions with chimeric monoclonal antibody (mAb) girentuximab, which has been shown to have excellent imaging capabilities for ccRCC. Here we studied the potential of fluorescence imaging to detect ccRCC tumors in nude mice with RCC xenografts by using mAb girentuximab conjugated with IRDye800CW; SPECT imaging was used as a reference.METHODSGroups of athymic BALB/c mice with subcutaneous CAIX-positive SK-RC-52 ccRCC tumors were injected intravenously with (125)I-labeled girentuximab-IRDye800CW or (125)I-labeled girentuximab. For determination of the specificity of the accumulation of the anti-CAIX antibody conjugate in ccRCC, separate groups of mice bearing a CAIX-positive tumor (SK-RC-52) and a CAIX-negative tumor (SK-RC-59) received (125)I-girentuximab-IRDye800CW or (125)I-labeled MOPC21-IRDye800CW (control mAb). Optical images and micro-SPECT images were acquired until 3 d after injection. Mice were euthanized after the last imaging session, and the biodistribution of the radiolabeled antibody preparations was determined.RESULTSOptical imaging and micro-SPECT imaging at 1 d after the injection of (125)I-girentuximab-IRDye800CW showed clear delineation of the CAIX-expressing ccRCC xenografts, and image contrast improved with time. Fluorescence imaging and biodistribution studies showed high and specific uptake of (125)I-girentuximab-IRDye800CW in CAIX-positive ccRCC xenografts (SK-RC-52, 31.5 ± 9.6 percentage injected dose per gram [%ID/g] at 72 h after injection). Tumor uptake was specific, as very low uptake of (125)I-girentuximab-IRDye800CW was noted in the CAIX-negative SK-RC-59 tumor (4.1 ± 1.5 %ID/g), and no uptake of (125)I-MOPC21-IRDye800CW (control mAb) was noted in the CAIX-positive SK-RC-52 tumor (1.2 ± 0.1 %ID/g).CONCLUSIONSubcutaneous CAIX-expressing ccRCC xenografts were visualized by optical imaging with (125)I-girentuximab-IRDye800CW. Optical images showed good concordance with micro-SPECT images. The accumulation of (125)I-girentuximab-IRDye800CW in ccRCC tumors was high and specific. Girentuximab-IRDye800CW potentially could be used for the intraoperative detection of CAIX-expressing tumors and the assessment of residual tumor in resection margins or metastatic lesions in patients with ccRCC.

100 Deals associated with Iodine (124I) Girentuximab

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External Link

KEGG	Wiki	ATC	Drug Bank
D09632	-	-	DB15025

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Transitional Cell Carcinoma	Phase 2	DE	Heidelberg Pharma Research GmbH	30 Jan 2022
Transitional Cell Carcinoma	Phase 2	AU	Telix Pharmaceuticals Ltd.	30 Jan 2022
Triple Negative Breast Cancer	Phase 1	AU	Telix Pharmaceuticals Ltd.	30 Jan 2022
Triple Negative Breast Cancer	Phase 1	DE	Heidelberg Pharma Research GmbH	30 Jan 2022
Renal Cell Carcinoma	Phase 1	AU	Telix Pharmaceuticals Ltd.	16 Jan 2017
Renal Cell Carcinoma	Phase 1	AU	Telix Pharmaceuticals Ltd.	16 Jan 2017
Kidney Neoplasms	Phase 1	US	Wilex GmbH Im- u. Export von Investitions- und Verbrauchsgüter	01 Mar 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00199888 (Pubmed \| Lancet Oncol)	Phase 1	Renal Cell Carcinoma	26	Iodine-124-labelled antibody chimeric G250	(nnkruvpsdo) = qlkbwgpmik pvymlnrywo (vfdoztdilt, 55 - 100) View more	-	01 Apr 2007