An open-label, single dose, dose finding, exploratory phase II trial of FG001 (an optical imaging agent) for intraoperative visualization of inadequate margins in subjects with oral squamous cell carcinoma.

开始日期2025-04-14

申办/合作机构

FluoGuide A/S

NCT06684795

/ Recruiting临床2期IIT

An Open-label, Non-randomized, Single Dose, Phase II Trial of FG001 (an Optical Imaging Agent) for Localization of Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery

In neurosurgery both the diffusely infiltrated gliomas of the brain as well as the border towards healthy tissue in the meninges is a challenge. For the high-grade contrast enhanced gliomas fluorescent drugs like Gliolan have been used in several years and proved its clinical value. For non-contrast enhanced gliomas, like low-grade glioma, no such drug exist. The transition zone towards healthy non-tumor cell infiltrated brain in such low-grade gliomas is extremely difficult but for these patients their prognosis depends on the amount of non-healthy tissue left behind. Also, in benign tumors as meningioma the complete resection including infiltrated meninges is of importance for the cure of the disease. None of the existing fluorescent drug is useful or approved for these tumors.. Hence a medicinal product that will fulfil the criteria for a safe and reliable fluorescent drug to guide the surgery to the boundaries of the infiltration with tumor cells is highly warranted.

开始日期2024-05-01

申办/合作机构

Rigshospitalet

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项与 FG-001 相关的文献（医药）

2025-12-01·NEUROSURGERY

Novel Urokinase-Type Plasminogen Activator Receptor-Targeting Optical Imaging Agent ICG-Glu-Glu-AE105 for Visualization of Malignant Glioma During Surgery: First-in-Human Study in 35 Patients with Brain Cancer

Article

作者: Skjøth-Rasmussen, Jane ; Sølling, Christine ; Kryspin Sørensen, Martin ; Ginsborg, Sara ; Kjaer, Andreas ; Azam, Aleena ; Scheie, David ; Winther Kristensen, Bjarne ; Juhl, Karina ; Larsen, Carl Christian

BACKGROUND AND OBJECTIVES::

Glioblastoma is an aggressive form of brain cancer for which surgery is the keystone in treatment before oncological treatment. Improving surgical resection without jeopardizing the outcome is eminent, and a fluorescent drug to aid surgical outcome is warranted. To evaluate the safety and the efficacy of a novel urokinase-type Plasminogen Activator Receptor-targeting near-infrared optical imaging agent, ICG-Glu-Glu-AE105 (FG001), in patients with malignant glioma (glioblastoma).

METHODS::

First-in-human phase I dose escalation and time elaboration study in 35 patients undergoing surgery for glioblastoma. The tumor-to-background ratio (TBR) was measured on near-infrared images as an objective measure of image contrast. Biopsies were taken during surgery from areas with and without fluorescence (FG001) and compared with pathology as reference. Efficacy was evaluated as sensitivity and specificity of FG001 to detect tumor tissue. The study was conducted with close safety monitoring.

RESULTS::

Administration of FG001 at a dose of 36 mg, 12 to 17 hours before surgery, resulted in optimal image contrast between tumor and normal brain tissue, with a mean TBR of 3.6. A high sensitivity (79%) and specificity (100%) for the detection of tumor tissue was found. Safety monitoring during the study identified only a few related adverse events, all of which were of mild grade.

CONCLUSION::

FG001 was found to be safe and well tolerated in the patients included in the study. The optimal dose of FG001 was selected on the basis of videos taken during the surgery and the measured TBR values. A dose of 36 mg administered 16 hours (mean) before the surgery showed the best contrast (TBR values) and optimal visualization of the tumor delineation. Histology demonstrated good sensitivity of FG001.

2025-08-02·ChemMedChem

Novel 4,5‐Dihydrothiazole‐Phenylpiperazine Derivatives: Synthesis, Docking Studies and Pharmacological Evaluation as Serotonergic Agents

Article

作者: Santagada, Vincenzo ; Sparaco, Rosa ; Kędzierska, Ewa ; Capasso, Raffaele ; Corvino, Angela ; Gawel, Kinga ; Gibuła‐Tarłowska, Ewa ; Caliendo, Giuseppe ; Lesniak, Anna ; Magli, Elisa ; Kaczor, Agnieszka A. ; Karkoszka, Natalia ; Biała, Grażyna ; Bielenica, Anna ; Severino, Beatrice ; Andreozzi, Giorgia ; Kotlińska, Jolanta H. ; Fiorino, Ferdinando ; Semenko, Nataliia

The synthesis of a new series of long‐chain arylpiperazine as serotoninergic ligands (FG 1‐18) is described. The combination of structural elements including heterocyclic nucleus, propyl chain, and 4,5‐dihydrothiazol‐2‐ylphenylpiperazines leads to the preparation of different derivatives tested for their affinity toward 5‐HT1A, 5‐HT2A, and 5‐HT2C receptors. The compounds with better affinity and selectivity binding profiles toward 5‐HT1A and 5‐HT2C (FG‐1, FG‐4, FG‐5, FG‐6, FG‐7, FG‐8, and FG‐18) are selected for further in vivo assays to determine their functional activity. Finally, to rationalize the obtained results, molecular docking studies are performed. The results of pharmacological studies show that compounds FG‐1, FG‐5, FG‐8, and FG‐6 exert antidepressant‐like effects, and FG‐1, FG‐18, FG‐6, and FG‐7 reveal also significant anxiolytic properties. Among the developed derivatives, the most promising compounds seem to be FG‐1, which exhibit antidepressant, anxiolytic, and anticonvulsant properties, FG‐7 and FG‐18 that show features as anxiolytic combine to a pro‐cognitive property and notable affinity and selectivity for 5‐HT2C receptor, respectively.

2025-01-01·Theranostics

Optical molecular imaging in oral- and oropharyngeal squamous cell carcinoma using a novel uPAR-targeting near-infrared imaging agent FG001 (ICG-glu-glu-AE105): An explorative phase II clinical trial

Article

作者: Kiss, Katalin ; Kjaer, Andreas ; von Buchwald, Christian ; Straede, Karina ; Poulsen, Anne ; Rubek, Nicklas ; Lawaetz, Mads ; Hahn, Christoffer Holst ; Lelkaitis, Giedrius ; Christensen, Anders ; Paaske, Natasja ; Wessel, Irene ; Andersen, Amanda Oester

Background: In oral and oropharyngeal squamous cell carcinoma (OSCC, OPSCC), frequent inadequate surgical margins highlight the importance of precise intraoperative identification and delineation of cancerous tissue for improving patient outcomes. Methods: A prospective, open-label, single-center, single dose, exploratory phase II clinical trial (EudraCT 2022-001361-12) to assess the efficacy of the novel uPAR-targeting near-infrared imaging agent, FG001, for intraoperative detection of OSCC and OPSCC. Macroscopic tumor detection was quantified with sensitivity and intraoperative tumor-to-background ratio (TBR). Microscopic tumor-specificity was assessed by analysis of morphological co-localization between tumor tissue, uPAR-expression, and optical signal. Blood samples were collected up to 44 hours post-injection to further characterize the pharmacokinetic profile of the agent. The trial was conducted with close safety monitoring. Results: Sixteen patients undergoing primary surgical resection were systemically administered 36 mg (n = 4), 16 mg (n = 8), or 4 mg (n = 4) of FG001 the evening prior to surgery. Intraoperatively, using a near-infrared imaging system, real-time optical imaging successfully identified all 16 tumors (sensitivity: 100%, mean TBR: 2.99 range: 2.02 - 3.95), and tumor-specificity was confirmed by histology. Clinical neck metastasis was detected with optical imaging. The maximal plasma concentrations were measured after 1 hour, and the half-life of FG001 was 12 hours. No drug-related or serious adverse events were observed. Conclusions: FG001 holds great potential for optical molecular imaging of OSCC and OPSCC. Further trials are warranted to explore FG001 for intraoperative margin delineation and as a decision-making tool.

项与 FG-001 相关的新闻（医药）

2026-01-21

·BioSpace

FluoGuide Submits an IND for FG001, to Initiate First U.S. Registration Trial

KØBENHAVN, DK / ACCESS Newswire / January 21, 2026 / FluoGuide A/S ("FluoGuide" or the "Company")(STO:FLUO), a biotech company maximizing surgical outcomes in oncology by lighting up cancer, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FG001. The IND supports the initiation of the Company's first registration trial in patients with high-grade glioma (HGG). The IND submission represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. Initiation of the first registration trial remains on track, with enrollment of the first patient expected in Q2 2026. IND submission - foundation for U.S. registration An Investigational New Drug (IND) application is required to obtain U.S. regulatory authorization to initiate clinical trials of a new drug. FG001 is a well-advanced, clinical-stage product, and significant portions of the submitted IND package, including the preclinical section, are expected to form the basis of the future New Drug Application (NDA) required to obtain approval to market FG001 in the U.S. Prior to submission, FluoGuide held a pre-IND meeting with FDA, during which the agency reviewed a comprehensive development package covering completed work and proposed plans for ongoing studies. Importantly, FluoGuide received FDA alignment on the design of its U.S. Phase 2 clinical trial in HGG to support registration, as well as on key elements of the subsequent Phase 3 program. This regulatory alignment provides a strong foundation for the long-term development planning, and in our view, de-risks the regulatory process as we advance toward NDA submission and future U.S. approval of FG001. First registration trial - clear regulatory path FluoGuide anticipates that two clinical trials will be required to support U.S. approval of FG001 for HGG. Both trials are expected to enroll patients over approximately one year, with final timelines and enrollment subject to emerging data and regulatory feedback. This program establishes a clear, structured and capital-efficient path toward U.S. approval of FG001 in HGG - one of the most aggressive forms of cancer. "The IND submission reflects focused execution across regulatory, clinical and technical disciplines. I am very proud of the FluoGuide team and our collaborating neurosurgeons for delivering a high-quality IND package that reflects the maturity of the FG001 program and supports a clear path toward U.S. registration trials in high-grade glioma - advancing our mission to maximize the outcomes for patients facing this highly aggressive brain cancer," said Donna Haire , COO of FluoGuide. "As we enter 2026, FluoGuide has reached a key inflection point. With the IND now submitted, we have further de-risked our lead program and established a well-defined regulatory path toward U.S. approval. Our mission remains unchanged: to maximizing outcomes in cancer surgery" said Morten Albrechtsen , CEO of FluoGuide and continue "We are now well positioned to advance toward registration". Following the IND submission, FluoGuide will continue preparations for the planned U.S. Phase 2 registration trial in high-grade glioma and will provide updates as appropriate, with first patient planned enrolled in Q2. For further information, please contact: Morten Albrechtsen, CEO FluoGuide A/S Phone: +45 24 25 62 66 E-mail: ma@fluoguide.com Certified Adviser: Svensk Kapitalmarknadsgranskning AB Website: About FluoGuide FluoGuide lights up cancer to maximize surgical outcomes in oncology. FluoGuide's lead product, FG001, is designed to improve surgical precision by lighting up cancer intraoperatively. The improved precision has a dual benefit - it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision enhances the likelihood of complete cure and lower healthcare costs. FluoGuide has demonstrated that FG001 is both effective and well tolerated in several phase II clinical trials. The lead indications of FG001 are aggressive brain cancer (glioblastoma) and oral head and neck cancer. FluoGuide has entered partnerships with leading MedTech companies with the aim of accelerating development and commercialization. FluoGuide is listed on Nasdaq First North Sweden under the ticker "FLUO". For more information on FG001 or FluoGuide's uPAR technology platform, please visit our home page Attachments FluoGuide submits an IND for FG001, to initiate first U.S. registration trial SOURCE: FluoGuide A/S View the original press release on ACCESS Newswire

临床2期临床申请

2026-01-21

·fluoguide.com

FluoGuide submits an IND for FG001, to initiate first U.S. registration trial

The IND submission represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. Initiation of the first registration trial remains on track, with enrollment of the first patient expected in Q2 2026. IND submission – foundation for U.S. registration An Investigational New Drug (IND) application is required to obtain U.S. regulatory authorization to initiate clinical trials of a new drug. FG001 is a well-advanced, clinical-stage product, and significant portions of the submitted IND package, including the preclinical section, are expected to form the basis of the future New Drug Application (NDA) required to obtain approval to market FG001 in the U.S. Prior to submission, FluoGuide held a pre-IND meeting with FDA, during which the agency reviewed a comprehensive development package covering completed work and proposed plans for ongoing studies. Importantly, FluoGuide received FDA alignment on the design of its U.S. Phase 2 clinical trial in HGG to support registration, as well as on key elements of the subsequent Phase 3 program. This regulatory alignment provides a strong foundation for the long-term development planning, and in our view, de-risks the regulatory process as we advance toward NDA submission and future U.S. approval of FG001. First registration trial – clear regulatory path FluoGuide anticipates that two clinical trials will be required to support U.S. approval of FG001 for HGG. Both trials are expected to enroll patients over approximately one year, with final timelines and enrollment subject to emerging data and regulatory feedback. This program establishes a clear, structured and capital-efficient path toward U.S. approval of FG001 in HGG – one of the most aggressive forms of cancer. “The IND submission reflects focused execution across regulatory, clinical and technical disciplines. I am very proud of the FluoGuide team and our collaborating neurosurgeons for delivering a high-quality IND package that reflects the maturity of the FG001 program and supports a clear path toward U.S. registration trials in high-grade glioma – advancing our mission to maximize the outcomes for patients facing this highly aggressive brain cancer,” said Donna Haire, COO of FluoGuide. “As we enter 2026, FluoGuide has reached a key inflection point. With the IND now submitted, we have further de-risked our lead program and established a well-defined regulatory path toward U.S. approval. Our mission remains unchanged: to maximizing outcomes in cancer surgery” said Morten Albrechtsen, CEO of FluoGuide and continue “We are now well positioned to advance toward registration”. Following the IND submission, FluoGuide will continue preparations for the planned U.S. Phase 2 registration trial in high-grade glioma and will provide updates as appropriate, with first patient planned enrolled in Q2.

临床2期申请上市临床申请

2025-12-19

·fluoguide.com

FluoGuide updates IND submission timing for FG001 – trial initiation unaffected

Copenhagen, Denmark, 19 December 2025 – FluoGuide A/S (“FluoGuide” or the “Company”), a biotech company specializing in precision cancer surgery, today announced an update to the submission date for its for its Investigational New Drug (IND) application to mid-January 2026. The updated timeline relates to the IND application supporting the first of two planned registration trials for FG001 in patients with high-grade glioma (HGG). The Company expects to submit the IND in mid-January 2026, compared to end-December 2025 as previously communicated. Importantly, this updated submission timing will have no impact on the planned initiation of the first registration trial for FG001. “I am thankful to our hard-working team and collaborating neurosurgeons for their focused efforts to complete the IND application, which is designed to guide surgery in patients with high-grade glioma,” said Morten Albrechtsen, CEO of FluoGuide.

临床申请临床研究

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适应症	最高研发状态	国家/地区	公司	日期
头颈部肿瘤	临床2期	丹麦	FluoGuide A/S	2022-01-30
高级别胶质瘤	临床2期	丹麦	FluoGuide A/S	2022-01-30
非小细胞肺癌	临床2期	丹麦	FluoGuide A/S	2022-01-30

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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


Pubmed 人工标引	临床1期	脑恶性胶质瘤 \| 脑癌	35	FG001	壓獵製鬱鹹鹽夢遞願願(憲襯餘願積顧積窪餘壓) = 鑰窪繭醖鬱衊窪淵簾鑰膚壓憲獵構憲願鏇願簾 (範選憲選顧蓋繭膚獵鹽 ) 更多	积极	2025-06-03
FG001-CT-001 (Corporate Publications) 人工标引	临床2期	高级别胶质瘤	24	FG001	遞鹽製顧鏇鑰願憲糧淵(衊鏇齋夢範廠艱醖觸鏇) = 範醖範獵遞顧淵遞壓醖膚醖積鑰鏇觸憲繭襯糧 (願鏇糧鏇蓋夢襯鏇顧顧 ) 达到更多	积极	2023-11-13
FG001-CT-001 (Corporate Publications) 人工标引	临床2期	高级别胶质瘤	24	5-ALA	遞鹽製顧鏇鑰願憲糧淵(衊鏇齋夢範廠艱醖觸鏇) = 憲蓋構鏇簾壓遞淵鹹齋膚醖積鑰鏇觸憲繭襯糧 (願鏇糧鏇蓋夢襯鏇顧顧 ) 达到	积极	2023-11-13
PipelineReview 人工标引	临床2期	头颈部肿瘤	16	FG001	範衊遞觸鏇製鬱淵願顧(鹹蓋範壓鹽襯廠憲齋願) = 願積鑰繭鹽窪鏇構廠蓋積選鬱積範鹹鬱願淵鑰 (積膚網夢獵蓋襯鏇鏇襯 )	积极	2023-11-06