Phase 1 Evaluation of [(64)Cu]DOTA-Patritumab to Assess Dosimetry, Apparent Receptor Occupancy, and Safety in Subjects with Advanced Solid Tumors.
Purpose: The purpose of this study was to evaluate the safety, dosimetry, and apparent receptor occupancy (RO) of [(64)Cu]DOTA-patritumab, a radiolabeled monoclonal antibody directed against HER3/ERBB3 in subjects with advanced solid tumors.Procedures: Dosimetry subjects (n = 5) received [(64)Cu]DOT...
| Publicado en: | Molecular Imaging & Biology Vol. 18; no. 3; pp. 446 - 454 |
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| Autores principales: | , , , , , , , , , , , , , , , |
| Formato: | clinical trial research Journal Article |
| Publicado: |
Springer Nature
Jun2016
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=115398027&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 115398027 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15361632 KJU jtl: Molecular Imaging & Biology issn: 15361632 maglogo: N pubinfo: dt: Jun2016 vid: 18 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 115398027 115398027 NLM26567113 115398027 10.1007/s11307-015-0912-y NLM26567113 115398027 ppf: 446 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Phase 1 Evaluation of [(64)Cu]DOTA-Patritumab to Assess Dosimetry, Apparent Receptor Occupancy, and Safety in Subjects with Advanced Solid Tumors. aug: au: Lockhart, A. Liu, Yongjian Dehdashti, Farrokh Laforest, Richard Picus, Joel Frye, Jennifer Trull, Lauren Belanger, Stefanie Desai, Madhuri Mahmood, Syed Mendell, Jeanne Welch, Michael Siegel, Barry Lockhart, A Craig Welch, Michael J Siegel, Barry A affil: Mallinckrodt Institute of Radiology, Washington University School of Medicine, 660 South Euclid Avenue St. Louis 63110 USA sug: subj: Antibodies Therapeutic Use Antibodies, Monoclonal Therapeutic Use Neoplasms Organometallic Compounds Adverse Effects Organometallic Compounds Therapeutic Use Antibodies Adverse Effects Radiometry Neoplasms Drug Therapy Antibodies, Monoclonal Adverse Effects Treatment Outcomes Tomography, Emission-Computed Organometallic Compounds Pharmacokinetics Human Receptors, Cell Surface Neoplasms Pathology Adult Antibodies, Monoclonal Middle Age Female Male Tomography, X-Ray Computed Neoplasm Staging Aged Clinical Trials Validation Studies Comparative Studies Evaluation Research Multicenter Studies Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Female Male ab: Purpose: The purpose of this study was to evaluate the safety, dosimetry, and apparent receptor occupancy (RO) of [(64)Cu]DOTA-patritumab, a radiolabeled monoclonal antibody directed against HER3/ERBB3 in subjects with advanced solid tumors.Procedures: Dosimetry subjects (n = 5) received [(64)Cu]DOTA-patritumab and underwent positron emission tomography (PET)/X-ray computed tomography (CT) at 3, 24, and 48 h. Evaluable RO subjects (n = 3 out of 6) received [(64)Cu]DOTA-patritumab at day 1 and day 8 (after 9.0 mg/kg patritumab) followed by PET/CT at 24 h post-injection. Endpoints included safety, tumor uptake, and efficacy.Results: The tumor SUVmax (± SD) was 5.6 ± 4.5, 3.3 ± 1.7, and 3.0 ± 1.1 at 3, 24, and 48 h in dosimetry subjects. The effective dose and critical organ dose (liver) averaged 0.044 ± 0.008 mSv/MBq and 0.46 ± 0.086 mGy/MBq, respectively. In RO subjects, tumor-to-blood ratio decreased from 1.00 ± 0.32 at baseline to 0.57 ± 0.17 after stable patritumab, corresponding to a RO of 42.1 ± 3.Conclusions: [(64)Cu]DOTA-patritumab was safe. These limited results suggest that this PET-based method can be used to determine tumor-apparent RO. pubtype: Academic Journal doctype: clinical trial research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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