([89Zr]Panitumumab(The University of Alabama at Birmingham)) - 药物靶点：EGFR_在研适应症：结肠癌，头颈部鳞状细胞癌_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-

靶点

EGFR

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、PET imaging(正电子发射断层成像术增强剂)

治疗领域

肿瘤消化系统疾病

在研适应症

结肠癌头颈部鳞状细胞癌

非在研适应症

结肠转移性腺癌

原研机构

The University of Alabama at Birmingham

在研机构

The University of Alabama at Birmingham

非在研机构-

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-

结构

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关联

7

项与 [89Zr]Panitumumab(The University of Alabama at Birmingham) 相关的临床试验

NCT05183048 / Recruiting早期临床1期IIT

Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma

This pilot clinical study will investigate if Zirconium-89 (89Zr) panitumumab- Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) imaging can more accurately determine size and location of primary tumors compared to standard of care Fludeoxyglucose (18F-FDG) -PET/MRI in newly diagnosed patients with head and neck squamous cell carcinoma (HNSCC) who are undergoing surgical resection. This study is for imaging purposes only and is not a treatment study. The results of this study will not change the clinical treatment plan.

开始日期2024-12-31

申办/合作机构

The University of Alabama at Birmingham

NCT05423197 / Not yet recruiting临床2期IIT

Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).

开始日期2024-06-01

申办/合作机构-

NCT05747625 / Recruiting临床1期IIT

Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer.
Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions.
Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).

开始日期2023-05-09

申办/合作机构-

100 项与 [89Zr]Panitumumab(The University of Alabama at Birmingham) 相关的临床结果

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100 项与 [89Zr]Panitumumab(The University of Alabama at Birmingham) 相关的转化医学

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100 项与 [89Zr]Panitumumab(The University of Alabama at Birmingham) 相关的专利（医药）

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13

项与 [89Zr]Panitumumab(The University of Alabama at Birmingham) 相关的文献（医药）

2023-07-01·International journal of radiation oncology, biology, physics

Preclinical Evaluation of 89Zr-Panitumumab for Biology-Guided Radiation Therapy

Article

作者: Liang, Xuanwei ; Chin, Frederick T ; Natarajan, Arutselvan ; Anders, David ; Malik, Noeen ; Pratx, Guillem ; Rosenthal, Eben ; Oderinde, Oluwaseyi M ; Das, Neeladrisingha ; Nguyen, Hieu ; Khan, Syamantak

PURPOSE:

Biology-guided radiation therapy (BgRT) uses real-time line-of-response data from on-board positron emission tomography (PET) detectors to guide beamlet delivery during therapeutic radiation. The current workflow requires ¹⁸F-fluorodeoxyglucose (FDG) administration daily before each treatment fraction. However, there are advantages to reducing the number of tracer injections by using a PET tracer with a longer decay time. In this context, we investigated ⁸⁹Zr-panitumumab (⁸⁹Zr-Pan), an antibody PET tracer with a half-life of 78 hours that can be imaged for up to 9 days using PET.

METHODS AND MATERIALS:

The BgRT workflow was evaluated preclinically in mouse colorectal cancer xenografts (HCT116) using small-animal positron emission tomography/computed tomography (PET/CT) for imaging and image-guided kilovoltage conformal irradiation for therapy. Mice (n = 5 per group) received 7 MBq of ⁸⁹Zr-Pan as a single dose 2 weeks after tumor induction, with or without fractionated radiation therapy (RT; 6 × 6.6 Gy) to the tumor region. The mice were imaged longitudinally to assess the kinetics of the tracer over 9 days. PET images were then analyzed to determine the stability of the PET signal in irradiated tumors over time.

RESULTS:

Mice in the treatment group experienced complete tumor regression, whereas those in the control group were killed because of tumor burden. PET imaging of ⁸⁹Zr-Pan showed well-delineated tumors with minimal background in both groups. On day 9 postinjection, tumor uptake of ⁸⁹Zr-Pan was 7.2 ± 1.7 in the control group versus 5.2 ± 0.5 in the treatment group (mean percentage of injected dose per gram of tissue [%ID/g] ± SD; P = .07), both significantly higher than FDG uptake (1.1 ± 0.5 %ID/g) 1 hour postinjection. To assess BgRT feasibility, the clinical eligibility criteria was computed using human-equivalent uptake values that were extrapolated from preclinical PET data. Based on this semiquantitative analysis, BgRT may be feasible for 5 consecutive days after a single 740-MBq injection of ⁸⁹Zr-Pan.

CONCLUSIONS:

This study indicates the potential of long-lived antibody-based PET tracers for guiding clinical BgRT.

2023-06-01·European journal of nuclear medicine and molecular imaging

[89Zr]-immuno-PET prediction of response to rituximab treatment in patients with therapy refractory interstitial pneumonitis: a phase 2 trial

Article

作者: Oyen, Wim J G ; van de Garde, E M W ; Grutters, J C ; Keijsers, R G ; Vugts, D J ; Adams, H

Introduction:

Immune-mediated interstitial pneumonitis may be treated with anti-CD20 therapy after failure of conventional therapies. However, clinical response is variable. It was hypothesized that autoreactive CD20-positive cells may play an important role in this variability. This prospective study aims to elucidate if imaging of CD20-positive cells in the lungs allows prediction of the response to anti-CD20 treatment.

Methods:

Twenty-one patients with immune-mediated interstitial lung disease (ILD) with deteriorated pulmonary function received a dose of 1000 mg rituximab on day 1 and day 14 spiked with a tracer dose of radiolabeled [89Zr]-rituximab. PET/CT was performed on days 3 and 6. Standardized uptake values (SUV) were calculated as a measure for pulmonary CD20 expression. Based on pulmonary function tests (PFT), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO), prior to and 6 months after treatment, patients were classified as responder (stable disease or improvement) or non-responder.

Results:

Fifteen patients (71%) were classified as responder. Pulmonary [89Zr]-rituximab PET SUVmean was significantly correlated with the change in FVC and DLCO (K = 0.49 and 0.56, respectively) when using target-to-background ratios, but not when using SUVmean alone. [89Zr]-rituximab SUVmean was significantly higher in responders than in non-responders (0.35 SD 0.09 vs. 0.23 SD 0.06; P = 0.02).

Conclusion:

Rituximab treatment was effective in the majority of patients. As a higher pulmonary uptake of [89Zr]-rituximab correlated with improvement of PFT and treatment outcome, [89Zr]-rituximab PET imaging may serve as a potential predictive biomarker for anti-CD20 therapy.

Trial registration:

Clinicaltrials.gov identifier NCT02251964

2022-10-14·Clinical cancer research : an official journal of the American Association for Cancer Research

89Zr-panitumumab Combined With 18F-FDG PET Improves Detection and Staging of Head and Neck Squamous Cell Carcinoma

Article

作者: Chin, Frederick T. ; Raymundo, Roan C. ; van den Berg, Nynke S. ; Hom, Marisa ; Rosenthal, Eben L. ; Shen, Bin ; Valencia, Alex ; Duan, Heying ; Colevas, A. Dimitrios ; Ferri, Valentina ; Iagaru, Andrei ; Martin, Brock A. ; Zhou, Quan ; Baik, Fred M. ; Koran, Mary Ellen ; Kaplan, Michael J. ; Lee, Yu-Jin ; Castillo, Jessa ; Freeman, Laura ; Azevedo, E. Carmen

Abstract:

Purpose::

Determine the safety and specificity of a tumor-targeted radiotracer (89Zr-pan) in combination with 18F-FDG PET/CT to improve diagnostic accuracy in head and neck squamous cell carcinoma (HNSCC).

Experimental Design::

Adult patients with biopsy-proven HNSCC scheduled for standard-of-care surgery were enrolled in a clinical trial and underwent systemic administration of 89Zirconium-panitumumab and panitumumab-IRDye800 followed by preoperative 89Zr-pan PET/CT and intraoperative fluorescence imaging. The sensitivity, specificity, and AUC were evaluated.

Results::

A total of fourteen patients were enrolled and completed the study. Four patients (28.5%) had areas of high 18F-FDG uptake outside the head and neck region with maximum standardized uptake values (SUVmax) greater than 2.0 that were not detected on 89Zr-pan PET/CT. These four patients with incidental findings underwent further workup and had no evidence of cancer on biopsy or clinical follow-up. Forty-eight lesions (primary tumor, LNs, incidental findings) with SUVmax ranging 2.0–23.6 were visualized on 18F-FDG PET/CT; 34 lesions on 89Zr-pan PET/CT with SUVmax ranging 0.9–10.5. The combined ability of 18F-FDG PET/CT and 89Zr-pan PET/CT to detect HNSCC in the whole body was improved with higher specificity of 96.3% [confidence interval (CI), 89.2%–100%] compared to 18F-FDG PET/CT alone with specificity of 74.1% (CI, 74.1%–90.6%). One possibly related grade 1 adverse event of prolonged QTc (460 ms) was reported but resolved in follow-up.

Conclusions::

89Zr-pan PET/CT imaging is safe and may be valuable in discriminating incidental findings identified on 18F-FDG PET/CT from true positive lesions and in localizing metastatic LNs.

100 项与 [89Zr]Panitumumab(The University of Alabama at Birmingham) 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
结肠转移性腺癌	临床2期	美国	The University of Alabama at Birmingham	2019-03-14
结肠癌	临床2期	-	The University of Alabama at Birmingham	-
头颈部鳞状细胞癌	临床1期	美国	The University of Alabama at Birmingham	2024-12-31

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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))	廠構壓廠積鑰鬱範獵鹹(網衊願膚製鏇憲夢淵構) = 構艱廠窪衊繭膚窪繭鏇餘壓構夢艱齋鹽衊築簾 (醖顧艱膚構淵夢範顧鬱, 遞廠鏇築衊襯膚鏇衊製 ~ 憲範鬱鑰夢構積壓獵鹽) 更多	-	2023-05-19
				Pearl Triology Imaging System+89-Zirconium (Zr-89) Panitumumab+Panitumumab-IRDye800 (Tumor-positive Lymph Nodes (by 18F-FDG Scan))	廠構壓廠積鑰鬱範獵鹹(網衊願膚製鏇憲夢淵構) = 願網願艱積壓醖憲醖醖餘壓構夢艱齋鹽衊築簾 (醖顧艱膚構淵夢範顧鬱, 鏇觸鑰鏇衊餘夢膚鹽淵 ~ 廠簾築糧襯夢鹽鬱獵醖) 更多