Cetuximab-IRDye800CW (University Medical Center Groningen)(Cetuximab-IRDye800CW (University Medical Center Groningen)) - 药物靶点：EGFR_在研适应症：胶质母细胞瘤，高级别胶质瘤，复发性阴茎癌_专利_临床

概要

基本信息

药物类型

抗体光敏剂缀合物

别名-

靶点

EGFR

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、诊断染料分子

治疗领域

肿瘤神经系统疾病消化系统疾病+ [2]

在研适应症

胶质母细胞瘤高级别胶质瘤复发性阴茎癌+ [1]

非在研适应症-

原研机构

Universitair Medisch Centrum Groningen

在研机构

University Medical Center Groningen

非在研机构-

最高研发阶段临床1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

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序列信息

Sequence Code 9505399H

当前序列信息引自: *****

Sequence Code 43254L

当前序列信息引自: *****

关联

16

项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的临床试验

NCT05929456 / Recruiting临床1期

Multispectral and Bimodal Fluorescent Guided Surgery (FGS) of High-grade Glioma for Refining Margin Assessment: A Phase 1 Dose Finding Study Using Cetuximab-IRDye800CW Combined With 5-ALA.

The MIRROR study is a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison to the standard of care (SOC), 5-ALA fluorescent imaging agent. The main research objectives of this study are:
To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery
To assess the safety and tolerability
To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging
The study population will consist of patients, aged ≥18 years, diagnosed with high-grade glioma and scheduled for surgery.

开始日期2023-05-05

申办/合作机构

University Medical Center Groningen

NCT05499065 / Recruiting临床2期

Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging

To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.

开始日期2023-03-01

申办/合作机构

University Medical Center Groningen

NCT05376202 / Completed临床1期

Fluorescent Guided Surgery in Penile Carcinoma Using Cetuximab-800IRDyeCW

The main treatment modality for Penile Squamous Cell Carcinoma (PSCC) is surgery with curative intent. In organ sparing surgery a tumor-positive margin of up to 36% exist. Tumor-positive surgical margins are an independent risk factor for local recurrence, which has been reported to be up to 18%. Tumor-positive margins always lead to extra, penile sparing surgery, which leads to longer hospitalization, higher exposure to anesthetic interventions and a worse psychological outcome.
Currently, no intraoperative imaging technique that provides real time feedback for resection margins exists in PSCC. Molecular fluorescence-guided Surgery (MFGS) using targeted near-infrared (NIR) optical contrast agents like for example Cetuximab-800CW is a promising technique to accommodate this need. Epidermal Growth Factor Receptor (EGFR) is overexpressed in PSCC and has safely and successfully been used as target for molecular imaging, particularly for assessment for tumor margins in head and neck squamous cell carcinoma (ICON study, UMCG1).

开始日期2022-03-07

申办/合作机构

University Medical Center Groningen

[+1]

100 项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的临床结果

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100 项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的转化医学

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100 项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的专利（医药）

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17

项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的文献（医药）

2024-12-01·International Journal of Biological Macromolecules

Pharmacokinetics and fate of free and encapsulated IRD800CW-labelled human BChE intravenously administered in mice

Article

作者: Lockridge, Oksana ; Shaihutdinova, Zukhra ; Pashirova, Tatiana ; Gabdurakhmanov, Kamil ; Vasileva, Olga ; Schopfer, Lawrence M ; Tatarinov, Dmitry ; Titova, Angelina ; Malanyeva, Albina ; Masson, Patrick ; Schopfer, Lawrence M. ; Dudnikov, Sergei

Human butyrylcholinesterase (BChE) is an efficient bioscavenger of toxicants. Highly purified BChE was labelled with the near infrared fluorescent IRDye800CW. The goal was to determine the pharmacokinetics and fate of enzyme in mice. BChE-IRDye800CW was encapsulated in polyethylene glycol-polypropylene sulfide-based spherical polymersome nanoreactors with the following characteristics: 140 nm diameter, ξ = -6 mV, PDI ≤ 0.2, 1 year stability. Encapsulation did not alter the functional properties of BChE. Free and encapsulated enzyme were injected intravenously to CD-1 mice (single dose of enzyme 1.5 mg/kg and PEG-PPS polymersomes 25 mg/kg) and were analyzed for 8 days using an in vivo imaging system. Results showed that the pharmacokinetic distribution α-phase of encapsulated BChE (t_1/2 = 17.6 h) was longer than for free enzyme (t_1/2 = 6.6 h). The mean half-time for elimination β-phase was 2-time longer for encapsulated enzyme than for free enzyme (150 vs 72 h). Transient changes in infrared fluorescence in organs showed that BChE is eliminated from liver. However, free and encapsulated enzymes were cleared via different pathways. This first study of pharmacokinetics and fate of BChE encapsulated in polymersomes initiates research of new formulations of bioscavengers aimed at increasing the residence time of enzymes in the blood stream.

2024-07-01·Molecular Pharmaceutics

Increasing the Dye Payload of Cetuximab-IRDye800CW Enables Photodynamic Therapy

Article

作者: Mahmoud, Doha ; Obaid, Girgis ; Cameron, Colin G ; Nguyen, Austin ; Shah, Nimit ; Alzhanova, Dina ; Malkoochi, Ashritha ; McFarland, Sherri A ; Ferruzzi, Jacopo ; Shafirstein, Gal ; Keown, Micah ; Brekken, Rolf ; Bhandari, Chanda ; Quaye, Maxwell

Cetuximab (Cet)-IRDye800CW, among other antibody-IRDye800CW conjugates, is a potentially effective tool for delineating tumor margins during fluorescence image-guided surgery (IGS). However, residual disease often leads to recurrence. Photodynamic therapy (PDT) following IGS is proposed as an approach to eliminate residual disease but suffers from a lack of molecular specificity for cancer cells. Antibody-targeted PDT offers a potential solution for this specificity problem. In this study, we show, for the first time, that Cet-IRDye800CW is capable of antibody-targeted PDT in vitro when the payload of dye molecules is increased from 2 (clinical version) to 11 per antibody. Cet-IRDye800CW (1:11) produces singlet oxygen, hydroxyl radicals, and peroxynitrite upon activation with 810 nm light. In vitro assays on FaDu head and neck cancer cells confirm that Cet-IRDye800CW (1:11) maintains cancer cell binding specificity and is capable of inducing up to ∼90% phototoxicity in FaDu cancer cells. The phototoxicity of Cet-IRDye800CW conjugates using 810 nm light follows a dye payload-dependent trend. Cet-IRDye800CW (1:11) is also found to be more phototoxic to FaDu cancer cells and less toxic in the dark than the approved chromophore indocyanine green, which can also act as a PDT agent. We propose that antibody-targeted PDT using high-payload Cet-IRDye800CW (1:11) could hold potential for eliminating residual disease postoperatively when using sustained illumination devices, such as fiber optic patches and implantable surgical bed balloon applicators. This approach could also potentially be applicable to a wide variety of resectable cancers that are amenable to IGS-PDT, using their respective approved full-length antibodies as a template for high-payload IRDye800CW conjugation.

2022-12-01·Photodiagnosis and Photodynamic Therapy

NIR-II nano fluorescence image guided hepatic carcinoma resection on cirrhotic patient

作者: Hu, Zhenhua ; Zhang, Zeyu ; Su, Song ; Tian, Jie ; Liu, Gang ; Zhang, Yang ; Fang, Cheng ; Li, Bo

Precise resection of hepatic carcinoma (HCC) remains challenging for cirrhotic patients. Cirrhosis not only effects intraoperative palpation, but can also cause severe false-positive problems to indocyanine green (ICG) fluorescence imaging. Herein, we report the application of a nano-scale probe IgG-IRDye800CW to achieve precise HCC resection from cirrhotic liver. A 66-year-old male patient with liver cancer received intravenous injection of IgG-IRDye800CW (10 mg) 6 days prior to surgery, and none adverse effects were observed. During the operation, the HCC lesion in the right liver lobe was specifically detected on the near-infrared window II (NIR-II) fluorescence images. The high-contrast NIR-II fluorescence delineated a clear margin to improve surgical precision. These clinical observations showed high safety and feasibility of applying IgG-IRDye800CW NIR-II fluorescence imaging to guide hepatic surgery and minimize hepatic function damage.

100 项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的药物交易

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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
胶质母细胞瘤	临床1期	荷兰	University Medical Center Groningen	2023-05-05
高级别胶质瘤	临床1期	荷兰	University Medical Center Groningen	2023-05-05
复发性阴茎癌	临床1期	荷兰	University Medical Center Groningen	2022-03-07
局部晚期直肠癌	临床1期	荷兰	University Medical Center Groningen	2020-11-13

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临床结果

适应症

分期

评价

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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


NCT02736578 (CTgov)	临床2期	胰腺腺癌	8	Cetuximab-IRDye800+Cetuximab (Cetuximab IRDye800, 50 mg)	艱鬱遞膚選壓齋餘簾淵(鏇蓋衊鹽醖製顧鑰遞鹽) = 選獵襯壓膚膚餘廠積願淵顧淵網範製觸廠願遞 (鏇範壓製襯鬱夢顧選餘, 衊鹽襯壓艱積繭獵壓蓋 ~ 夢願顧顧壓鹽襯衊範壓) 更多	-	2019-02-01
				Cetuximab-IRDye800+Cetuximab (Cetuximab IRDye800, 100 mg)	糧鏇夢蓋遞鹹築範夢鹹(構艱鹽遞窪獵製蓋獵構) = 憲壓鹹夢選鬱衊鹹構餘鑰鹹遞夢齋築鹽襯醖獵 (餘積築膚願繭遞觸餘選, 餘繭鏇淵簾蓋夢衊醖鹹 ~ 顧積餘糧醖醖顧糧願選) 更多
NCT04161560 (Pubmed \| J Neurooncol)	临床1期	胶质母细胞瘤	3	Cetuximab-IRDye800 50mg	(獵鏇鏇鏇鏇廠鏇壓鑰製) = 選網淵壓廠鬱遞襯壓積構鏇積築蓋積鑰衊獵選 (範蓋餘鹹願齋構齋餘壓 ) 更多	-	2018-08-01
				Cetuximab-IRDye800 100mg	(獵鏇鏇鏇鏇廠鏇壓鑰製) = 齋願鏇餘窪衊願繭範膚構鏇積築蓋積鑰衊獵選 (範蓋餘鹹願齋構齋餘壓 ) 更多