Delving into the Latest Updates on Cetuximab-IRDye800CW (University Medical Center Groningen) with Synapse

Overview

Basic Info

Drug Type

Antibody-photosensitizer conjugates

Synonyms-

Target

EGFR

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), Diagnostic dye

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [2]

Active Indication

GlioblastomaHigh grade gliomaRelapsed Penile Carcinoma+ [1]

Inactive Indication-

Originator Organization

Universitair Medisch Centrum Groningen

Active Organization

University Medical Center Groningen

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure

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Gene Sequence

Sequence Code 9505399H

The sequence is quoted from: *****

Sequence Code 43254L

The sequence is quoted from: *****

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.

Start Date05 May 2023

Sponsor / Collaborator

University Medical Center Groningen

NCT05499065 / RecruitingPhase 2

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.

Start Date01 Mar 2023

Sponsor / Collaborator

University Medical Center Groningen

NCT05376202 / CompletedPhase 1

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).

Start Date07 Mar 2022

Sponsor / Collaborator

University Medical Center Groningen

[+1]

100 Clinical Results associated with Cetuximab-IRDye800CW (University Medical Center Groningen)

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100 Translational Medicine associated with Cetuximab-IRDye800CW (University Medical Center Groningen)

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100 Patents (Medical) associated with Cetuximab-IRDye800CW (University Medical Center Groningen)

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17

Literatures (Medical) associated with Cetuximab-IRDye800CW (University Medical Center Groningen)

01 Dec 2024·International Journal of Biological Macromolecules

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

Article

Author: 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.

01 Jul 2024·Molecular Pharmaceutics

Increasing the Dye Payload of Cetuximab-IRDye800CW Enables Photodynamic Therapy

Article

Author: 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.

01 Dec 2022·Photodiagnosis and Photodynamic Therapy

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

Author: 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 Deals associated with Cetuximab-IRDye800CW (University Medical Center Groningen)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma	Phase 1	NL	University Medical Center Groningen	05 May 2023
High grade glioma	Phase 1	NL	University Medical Center Groningen	05 May 2023
Relapsed Penile Carcinoma	Phase 1	NL	University Medical Center Groningen	07 Mar 2022
Locally Advanced Rectal Carcinoma	Phase 1	NL	University Medical Center Groningen	13 Nov 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02736578 (CTgov)	Phase 2	Pancreatic adenocarcinoma	8	Cetuximab-IRDye800+Cetuximab (Cetuximab IRDye800, 50 mg)	jicaouxzlm(oxtkafberi) = hdfxqshzbt xngmywiqlg (vudpmnjxbs, rbmrtwqavi - naohzougyk) View more	-	01 Feb 2019
				Cetuximab-IRDye800+Cetuximab (Cetuximab IRDye800, 100 mg)	mvwedocicc(mvehabqufh) = rpnmljenoh ymnvrvqdfv (zksexsnfys, ggtrtzlpbn - nrrycmxxau) View more
NCT04161560 (Pubmed \| J Neurooncol)	Phase 1	Glioblastoma	3	Cetuximab-IRDye800 50mg	(rilsuigxbx) = rhvfxdprfz auzkuwknta (ifngtbjzok ) View more	-	01 Aug 2018
				Cetuximab-IRDye800 100mg	(rilsuigxbx) = wpxorheifc auzkuwknta (ifngtbjzok ) View more