碘[124I]吉伦昔单抗(Iodine (124I) Girentuximab) - 药物靶点：CAIX_在研适应症：尿路上皮癌，三阴性乳腺癌_专利_临床

概要

基本信息

药物类型

抗体偶联核素、诊断用放射药物

别名

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

+ [7]

靶点

CAIX

作用机制

CAIX抑制剂(碳酸酐酶IX抑制剂)、PET imaging(正电子发射断层成像术增强剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Telix Pharmaceuticals Ltd.Heidelberg Pharma Research GmbH

非在研机构

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

Heidelberg Pharma AG

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

使用我们的ADC技术数据为新药研发加速。

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序列信息

Sequence Code 143780L

来源: *****

Sequence Code 143552H

来源: *****

关联

4

项与碘[124I]吉伦昔单抗相关的临床试验

NCT01762592 / Withdrawn临床3期

A Study of Iodine (124I) Girentuximab PET/CT Scan for the Detection of Clear Cell Renal Cell Carcinoma in Patients With Indeterminate cT1 Renal Masses

Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate cT1-renal masses.

开始日期2017-12-01

申办/合作机构

Heidelberg Pharma AG

NCT01582204 / Active, not recruitingN/AIIT

Pilot Trial To Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma

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.

开始日期2012-04-01

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+1]

NCT00606632 / Completed临床3期

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.

开始日期2008-03-01

申办/合作机构

Heidelberg Pharma AG

100 项与碘[124I]吉伦昔单抗相关的临床结果

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100 项与碘[124I]吉伦昔单抗相关的转化医学

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100 项与碘[124I]吉伦昔单抗相关的专利（医药）

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5

项与碘[124I]吉伦昔单抗相关的文献（医药）

2018-03-01·Current Opinion in Urology4区 · 医学

The role of molecular imaging in the characterization of renal masses

4区 · 医学

Review

作者: 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.

2015-01-01·Indian Journal of Urology

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

Article

作者: 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.

2014-06-01·Journal of Nuclear Medicine1区 · 医学

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

1区 · 医学

Article

作者: 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 项与碘[124I]吉伦昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09632	-	-	DB15025

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
尿路上皮癌	临床2期	德国	Heidelberg Pharma Research GmbH	2022-01-30
尿路上皮癌	临床2期	澳大利亚	Telix Pharmaceuticals Ltd.	2022-01-30
三阴性乳腺癌	临床1期	澳大利亚	Telix Pharmaceuticals Ltd.	2022-01-30
三阴性乳腺癌	临床1期	德国	Heidelberg Pharma Research GmbH	2022-01-30
肾细胞癌	临床1期	澳大利亚	Telix Pharmaceuticals Ltd.	2017-01-16
肾细胞癌	临床1期	澳大利亚	Telix Pharmaceuticals Ltd.	2017-01-16
肾肿瘤	临床1期	美国	Wilex GmbH Im- u. Export von Investitions- und Verbrauchsgüter	2008-03-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00199888 (Pubmed \| Lancet Oncol)	临床1期	肾细胞癌	26	Iodine-124-labelled antibody chimeric G250	(衊遞醖廠壓壓顧繭鹹積) = 衊網餘窪憲餘糧範觸廠壓廠構鏇鹹襯醖獵網簾 (選簾鏇夢醖鹹遞廠獵醖, 55 ~ 100) 更多	-	2007-04-01