Panitumumab-IRDye800CW(Stanford University)(Panitumumab-IRDye800CW(Stanford University)) - 药物靶点：EGFR_在研适应症：脑癌，继发性肺恶性肿瘤，听神经瘤_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

作用方式

拮抗剂

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)

治疗领域

肿瘤神经系统疾病呼吸系统疾病+ [3]

在研适应症

脑癌继发性肺恶性肿瘤听神经瘤+ [4]

非在研适应症-

原研机构

Stanford University

在研机构

The Vanderbilt-Ingram Cancer Center

Stanford University

非在研机构-

权益机构-

最高研发阶段临床1/2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/序列

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关联

11

项与 Panitumumab-IRDye800CW(Stanford University) 相关的临床试验

NCT07493447

/ Not yet recruiting早期临床1期IIT

Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures

This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.

开始日期2026-05-02

申办/合作机构

The Vanderbilt-Ingram Cancer Center

NCT04085887

/ Recruiting临床1/2期IIT

Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures

The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

开始日期2026-04-01

申办/合作机构

Stanford University

NCT06819228

/ Recruiting早期临床1期IIT

Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer

This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an anti-cancer agent in other cancers such as colorectal cancer. It works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. In addition to the Panitumumab, participants will also receive a Panitumumab-IRDye800 (Pan800) or a fluorescently labeled Panitumumab infusion. IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery.
The goal of this study is to use a novel and possibly safer approach to identify an optimal dose for panitumumab to treat cancer patients by using a new light-based therapy. In this study, different drug levels will be analyzed using this approach to understand how much drug reaches the tumor at different administered doses, which may help us provide safer and/or more effective therapies in the future.
The goal is to identify the correct amount or dose of a drug that is needed for effective cancer therapies. Often, clinical studies look at how much of the drug can be tolerated before patients become sick, rather than how much of the drug is required to be effective.
IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery. This will help the surgeon with clinical margins during surgery and will may have a clearer way to differentiate between cancer and healthy tissue.

开始日期2025-04-17

申办/合作机构

The Vanderbilt-Ingram Cancer Center

100 项与 Panitumumab-IRDye800CW(Stanford University) 相关的临床结果

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100 项与 Panitumumab-IRDye800CW(Stanford University) 相关的转化医学

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100 项与 Panitumumab-IRDye800CW(Stanford University) 相关的专利（医药）

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12

项与 Panitumumab-IRDye800CW(Stanford University) 相关的文献（医药）

2024-09-13·CLINICAL CANCER RESEARCH

Interim Phase II Results Using Panitumumab-IRDye800CW during Transoral Robotic Surgery in Patients with Oropharyngeal Cancer

Article

作者: Li, Yufeng ; Li, Mei ; Thomas, Carissa M. ; Jeyarajan, Harishanker ; James, Sherin ; Greene, Benjamin ; Stone, Logan D. ; Moore, Lindsay S. ; Panuganti, Bharat ; Fuson, Andrew ; Stevens, Todd M. ; Gonzalez, Manuel. L. ; McCammon, Susan ; Lin, Diana ; Rao, Shilpa ; Rosenthal, Eben L. ; Nabell, Lisle M. ; Kasten, Benjamin B. ; Bailey, Luke ; Carroll, William ; Warram, Jason M. ; Hartman, Yolanda E.

Abstract:

Purpose::

The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has continually increased during the past several decades. Using transoral robotic surgery (TORS) significantly improves functional outcomes relative to open surgery for OPSCC. However, TORS limits tactile feedback, which is often the most important element of cancer surgery. Fluorescence-guided surgery (FGS) strategies to aid surgeon assessment of malignancy for resection are in various phases of clinical research but exhibit the greatest potential impact for improving patient care when the surgeon receives limited tactile feedback, such as during TORS. Here, we assessed the feasibility of intraoperative fluorescence imaging using panitumumab-IRDye800CW (PAN800) during TORS in patients with OPSCC.

Patients and Methods::

Twelve consecutive patients with OPSCC were enrolled as part of a nonrandomized, prospective, phase II FGS clinical trial using PAN800. TORS was performed with an integrated robot camera for surgeon assessment of fluorescence. Intraoperative and ex vivo fluorescence signals in tumors and normal tissue were quantified and correlated with histopathology.

Results::

Intraoperative robot fluorescence views delineated OPSCC from normal tissue throughout the TORS procedure (10.7 mean tumor-to-background ratio), including in tumors with low expression of the molecular target. Tumor-specific fluorescence was consistent with surgeon-defined tumor borders requiring resection. Intraoperative robot fluorescence imaging revealed an OPSCC fragment initially overlooked during TORS based on brightfield views, further substantiating the clinical benefit of this FGS approach.

Conclusions::

The results from this patient with OPSCC cohort support further clinical assessment of FGS during TORS to aid resection of solid tumors.

2022-08-01·JOURNAL OF NUCLEAR MEDICINE1区 · 医学

Fluorescent Molecular Imaging Can Improve Intraoperative Sentinel Margin Detection in Oral Squamous Cell Carcinoma

1区 · 医学

Article

作者: van Keulen, Stan ; Condon, James ; Krishnan, Giri ; Farkurnejad, Shayan ; Pei, Jaqueline ; Kapoor, Shrey ; Nishio, Naoki ; Lee, Yu-Jin ; van den Berg, Nynke S ; Rosenthal, Eben L ; Zhou, Quan ; Freeman, Laura ; Baik, Fred M ; Martin, Brock A

In head and neck cancer, a major limitation of current intraoperative margin analysis is the ability to detect areas most likely to be positive based on specimen palpation, especially for larger specimens where sampling error limits detection of positive margins. This study aims to prospectively examine the clinical value of fluorescent molecular imaging to accurately identify "the sentinel margin," the point on a specimen at which the tumor lies closest to the resected edge in real-time during frozen section analysis. Methods: Eighteen patients with oral squamous cell carcinoma were enrolled into a prospective clinical trial and infused intravenously with 50 mg of panitumumab-IRDye800CW 1-5 d before surgery. Resected specimens were imaged in a closed-field near-infrared optical imaging system in near real-time, and custom-designed software was used to identify locations of highest fluorescence on deep and peripheral margins. The surgeon identified the sentinel margin masked to optical specimen mapping, and then the regions of highest fluorescence were identified and marked for frozen analysis. Final pathology based on specimen reconstruction was used as reference standard. Results: Resected specimens were imaged in the operating room, and fluorescence had a higher interobserver agreement with pathology (Cohen κ value 0.96) than the surgeon (Cohen κ value of 0.82) for the location of the closest margin. Plotting margin distance at the predicted sentinel margin location of each observer versus the actual closest margin distance at pathology demonstrated best correlation between fluorescence and pathology (R² = 0.98) with surgeon (R² = 0.75). Conclusion: Fluorescence imaging can improve identification of the sentinel margin in head and neck cancer resections, holding promise for rapid identification of positive margins and improved oncologic outcomes.

2022-06-01·CLINICAL CANCER RESEARCH1区 · 医学

First Clinical Results of Fluorescence Lifetime-enhanced Tumor Imaging Using Receptor-targeted Fluorescent Probes

1区 · 医学

Article

作者: Varvares, Mark A. ; Faquin, William ; Saladi, Srinivas V. ; van den Berg, Nynke S. ; Kumar, Anand T.N. ; Lwin, Thinzar M. ; Yang, Eric ; Hom, Marisa E. ; Pal, Rahul ; Rosenthal, Eben L. ; Prilutskiy, Andrey ; Lee, Yu-Jin

Abstract:

Purpose::

Fluorescence molecular imaging, using cancer-targeted near infrared (NIR) fluorescent probes, offers the promise of accurate tumor delineation during surgeries and the detection of cancer specific molecular expression in vivo. However, nonspecific probe accumulation in normal tissue results in poor tumor fluorescence contrast, precluding widespread clinical adoption of novel imaging agents. Here we present the first clinical evidence that fluorescence lifetime (FLT) imaging can provide tumor specificity at the cellular level in patients systemically injected with panitumumab-IRDye800CW, an EGFR-targeted NIR fluorescent probe.

Experimental Design::

We performed wide-field and microscopic FLT imaging of resection specimens from patients injected with panitumumab-IRDye800CW under an FDA directed clinical trial.

Results::

We show that the FLT within EGFR-overexpressing cancer cells is significantly longer than the FLT of normal tissue, providing high sensitivity (>98%) and specificity (>98%) for tumor versus normal tissue classification, despite the presence of significant nonspecific probe accumulation. We further show microscopic evidence that the mean tissue FLT is spatially correlated (r > 0.85) with tumor-specific EGFR expression in tissue and is consistent across multiple patients. These tumor cell-specific FLT changes can be detected through thick biological tissue, allowing highly specific tumor detection and noninvasive monitoring of tumor EFGR expression in vivo.

Conclusions::

Our data indicate that FLT imaging is a promising approach for enhancing tumor contrast using an antibody-targeted NIR probe with a proven safety profile in humans, suggesting a strong potential for clinical applications in image guided surgery, cancer diagnostics, and staging.

100 项与 Panitumumab-IRDye800CW(Stanford University) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
脑癌	临床2期	美国	Stanford University	2026-04-01
头颈部鳞状细胞癌	临床2期	美国	Stanford University	2019-08-01
继发性肺恶性肿瘤	临床2期	美国	Stanford University	2018-07-19
听神经瘤	临床1期	-	The Vanderbilt-Ingram Cancer Center	2026-05-02
胶质母细胞瘤	临床1期	-	The Vanderbilt-Ingram Cancer Center	2026-05-02
脑膜瘤	临床1期	-	The Vanderbilt-Ingram Cancer Center	2026-05-02
垂体腺瘤	临床1期	-	The Vanderbilt-Ingram Cancer Center	2026-05-02

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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


NCT03733210 (CTgov)	临床1期	头颈部鳞状细胞癌	14	Pearl Triology Imaging System+89-Zirconium (Zr-89) Panitumumab+Panitumumab-IRDye800 (Tumor-negative Lymph Nodes (by 18F-FDG Scan))	鏇壓鹽鏇選壓壓遞製獵 = 選鏇夢鏇鏇築夢夢醖艱構獵積構窪構廠衊獵壓 (遞窪齋遞觸糧網艱獵網, 觸憲餘衊繭鏇襯鬱糧觸 ~ 網壓積觸積膚選醖衊醖) 更多	-	2023-05-19
				Pearl Triology Imaging System+89-Zirconium (Zr-89) Panitumumab+Panitumumab-IRDye800 (Tumor-positive Lymph Nodes (by 18F-FDG Scan))	鏇壓鹽鏇選壓壓遞製獵 = 範齋襯築獵鹽網壓襯觸構獵積構窪構廠衊獵壓 (遞窪齋遞觸糧網艱獵網, 襯獵廠繭齋壓醖觸顧觸 ~ 憲餘製艱糧廠餘憲簾艱) 更多
NCT03405142 (CTgov)	临床2期	头颈部鳞状细胞癌	3	Panitumumab-IRDye800+Lymphoseek (T1 or T2 Stage and Node-negative)	範顧壓夢淵窪夢顧夢獵 = 淵鑰鑰壓淵廠衊簾鑰鏇醖壓窪衊網遞積鹽齋淵 (鬱網鹹窪壓構遞壓構遞, 蓋憲餘膚艱鹹範鏇鬱艱 ~ 選鑰廠醖網顧獵窪選淵) 更多	-	2022-11-10
				Panitumumab-IRDye800 (Any T Stage and Node-positive)	範顧壓夢淵窪夢顧夢獵 = 獵願鹹選憲壓壓鏇鹹醖醖壓窪衊網遞積鹽齋淵 (鬱網鹹窪壓構遞壓構遞, 構選顧蓋觸膚獵顧觸製 ~ 鹽齋選選淵鹹獵鹽餘衊) 更多