Delving into the Latest Updates on [89Zr]Panitumumab(The University of Alabama at Birmingham) with Synapse

Overview

Basic Info

Drug Type

Radiolabeled antibody, Diagnostic radiopharmaceuticals

Synonyms-

Target

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), PET imaging(Positron-emission tomography enhancers)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Colonic CancerSquamous Cell Carcinoma of Head and Neck

Inactive Indication

Metastatic colon cancer

Originator Organization

The University of Alabama at Birmingham

Active Organization

The University of Alabama at Birmingham

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 103929L

The sequence is quoted from: *****

Sequence Code 194636H

The sequence is quoted from: *****

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.

Start Date31 Dec 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05423197 / Not yet recruitingPhase 2IIT

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).

Start Date01 Jun 2025

Sponsor / Collaborator

Stanford University

NCT05747625 / RecruitingPhase 1IIT

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).

Start Date09 May 2023

Sponsor / Collaborator

The Vanderbilt-Ingram Cancer Center

100 Clinical Results associated with [89Zr]Panitumumab(The University of Alabama at Birmingham)

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100 Translational Medicine associated with [89Zr]Panitumumab(The University of Alabama at Birmingham)

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100 Patents (Medical) associated with [89Zr]Panitumumab(The University of Alabama at Birmingham)

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12

Literatures (Medical) associated with [89Zr]Panitumumab(The University of Alabama at Birmingham)

01 Jul 2023·International journal of radiation oncology, biology, physics

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

Article

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

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.

01 Jun 2023·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

Author: van de Garde, E M W ; Oyen, Wim J G ; 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

14 Oct 2022·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

Author: Chin, Frederick T. ; Raymundo, Roan C. ; van den Berg, Nynke S. ; Hom, Marisa ; Shen, Bin ; Rosenthal, Eben L. ; Duan, Heying ; Valencia, Alex ; Colevas, A. Dimitrios ; Ferri, Valentina ; Iagaru, Andrei ; Martin, Brock A. ; Baik, Fred M. ; Zhou, Quan ; 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 Deals associated with [89Zr]Panitumumab(The University of Alabama at Birmingham)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic colon cancer	Phase 2	US	The University of Alabama at Birmingham	14 Mar 2019
Colonic Cancer	Phase 2	-	The University of Alabama at Birmingham	-
Squamous Cell Carcinoma of Head and Neck	Phase 1	US	The University of Alabama at Birmingham	31 Dec 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03733210 (CTgov)	Phase 1	Squamous Cell Carcinoma of Head and Neck	14	Pearl Triology Imaging System+89-Zirconium (Zr-89) Panitumumab+Panitumumab-IRDye800 (Tumor-negative Lymph Nodes (by 18F-FDG Scan))	kxonejtgbj(ttxkcpqzyw) = uinelsrvxe icuoqfpsnf (susdpppagu, ikkdqgsfyx - ypdbsyhodd) View more	-	19 May 2023
				Pearl Triology Imaging System+89-Zirconium (Zr-89) Panitumumab+Panitumumab-IRDye800 (Tumor-positive Lymph Nodes (by 18F-FDG Scan))	kxonejtgbj(ttxkcpqzyw) = ubzdliezsd icuoqfpsnf (susdpppagu, fsdsofhoge - egjfytkklj) View more