Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors

Vascular endothelial growth factor; Advanced solid tumors; Nanobody

Detalles Bibliográficos
Autores: Le Tourneau, Christophe, Becker, Heiko, Claus, Rainer, Ricci, Francesco, Fritsch, R., Elez, Elena, Tabernero, Josep
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Departament de Salut de la Generalitat de Catalunya (DS)
Repositorio:Scientia. Dipòsit d'Informació Digital del Departament de Salut
OAI Identifier:oai:scientiasalut.gencat.cat:11351/9661
Acceso en línea:https://hdl.handle.net/11351/9661
Access Level:acceso abierto
Palabra clave:Càncer - Tractament
Angiogènesi - Inhibidors - Ús terapèutic
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Growth Substances::Angiogenesis Modulating Agents::Angiogenesis Inhibitors
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::sustancias del crecimiento::moduladores de la angiogénesis::inhibidores de la angiogénesis
Otros calificadores::Otros calificadores::/uso terapéutico
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oai_identifier_str oai:scientiasalut.gencat.cat:11351/9661
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors
title Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors
spellingShingle Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors
Le Tourneau, Christophe
Càncer - Tractament
Angiogènesi - Inhibidors - Ús terapèutic
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Growth Substances::Angiogenesis Modulating Agents::Angiogenesis Inhibitors
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::sustancias del crecimiento::moduladores de la angiogénesis::inhibidores de la angiogénesis
Otros calificadores::Otros calificadores::/uso terapéutico
title_short Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors
title_full Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors
title_fullStr Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors
title_full_unstemmed Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors
title_sort Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors
dc.creator.none.fl_str_mv Le Tourneau, Christophe
Becker, Heiko
Claus, Rainer
Ricci, Francesco
Fritsch, R.
Elez, Elena
Tabernero, Josep
author Le Tourneau, Christophe
author_facet Le Tourneau, Christophe
Becker, Heiko
Claus, Rainer
Ricci, Francesco
Fritsch, R.
Elez, Elena
Tabernero, Josep
author_role author
author2 Becker, Heiko
Claus, Rainer
Ricci, Francesco
Fritsch, R.
Elez, Elena
Tabernero, Josep
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Le Tourneau C] Department of Drug Development and Innovation (D3i), Institut Curie, INSERM U900 Research Unit, Paris-Saclay University, Paris & Saint-Cloud, France. [Becker H, Fritsch R] Department of Medicine I (Hematology, Oncology and Stem Cell Transplantation), Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. [Claus R] Department of Medicine I (Hematology, Oncology and Stem Cell Transplantation), Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Medical Faculty Augsburg University, Augsburg, Germany. [Elez E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Ricci F] Department of Drug Development and Innovation (D3i), Institut Curie, INSERM U900 Research Unit, Paris-Saclay University, Paris & Saint-Cloud, France. [Tabernero J] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IOB-Quiron, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Càncer - Tractament
Angiogènesi - Inhibidors - Ús terapèutic
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Growth Substances::Angiogenesis Modulating Agents::Angiogenesis Inhibitors
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::sustancias del crecimiento::moduladores de la angiogénesis::inhibidores de la angiogénesis
Otros calificadores::Otros calificadores::/uso terapéutico
topic Càncer - Tractament
Angiogènesi - Inhibidors - Ús terapèutic
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Growth Substances::Angiogenesis Modulating Agents::Angiogenesis Inhibitors
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::sustancias del crecimiento::moduladores de la angiogénesis::inhibidores de la angiogénesis
Otros calificadores::Otros calificadores::/uso terapéutico
description Vascular endothelial growth factor; Advanced solid tumors; Nanobody
publishDate 2022
dc.date.none.fl_str_mv 2022
2023
2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/9661
url https://hdl.handle.net/11351/9661
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv ESMO Open;7(5)
https://doi.org/10.1016/j.esmoop.2022.100576
dc.rights.none.fl_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv Scientia
reponame:Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname:Departament de Salut de la Generalitat de Catalunya (DS)
instname_str Departament de Salut de la Generalitat de Catalunya (DS)
reponame_str Scientia. Dipòsit d'Informació Digital del Departament de Salut
collection Scientia. Dipòsit d'Informació Digital del Departament de Salut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869422722874867712
spelling Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumorsLe Tourneau, ChristopheBecker, HeikoClaus, RainerRicci, FrancescoFritsch, R.Elez, ElenaTabernero, JosepCàncer - TractamentAngiogènesi - Inhibidors - Ús terapèuticDISEASES::NeoplasmsOther subheadings::Other subheadings::Other subheadings::/drug therapyCHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Growth Substances::Angiogenesis Modulating Agents::Angiogenesis InhibitorsOther subheadings::Other subheadings::/therapeutic useENFERMEDADES::neoplasiasOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaCOMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::sustancias del crecimiento::moduladores de la angiogénesis::inhibidores de la angiogénesisOtros calificadores::Otros calificadores::/uso terapéuticoVascular endothelial growth factor; Advanced solid tumors; NanobodyFactor de crecimiento endotelial vascular; Tumores sólidos avanzados; NanocuerpoFactor de creixement endotelial vascular; Tumors sòlids avançats; NanocosBackground BI 836880 is a humanized bispecific nanobody® that inhibits vascular endothelial growth factor and angiopoietin-2. Here, we report results from two phase I, nonrandomized, dose-escalation studies (NCT02674152 and NCT02689505; funded by Boehringer Ingelheim) evaluating BI 836880 in patients with confirmed locally advanced or metastatic solid tumors, refractory to standard therapy, or for which standard therapy was ineffective. Patients and Methods Patients aged ≥18 years, with an Eastern Cooperative Oncology Group performance status of 0-2 and adequate organ function received escalating intravenous doses of BI 836880 once every 3 weeks (Q3W; Study 1336.1) or once weekly (QW; Study 1336.6). Primary objectives were maximum tolerated dose (MTD) and recommended phase II dose of BI 836880, based on dose-limiting toxicities (DLTs) during the first cycle. Results Patients received one of five dosages of 40-1000 mg Q3W (29 patients) or 40-240 mg QW (24 patients). One DLT occurred with Q3W treatment [Grade (G) 3 pulmonary embolism (1000 mg)]. Five DLTs occurred in four patients treated QW [G2 proteinuria (120 mg); G3 hypertension (180 mg); G3 proteinuria and G3 hypertension (240 mg); and G4 respiratory distress (240 mg)]. All patients experienced adverse events, most commonly hypertension with Q3W treatment (89.7%; G3 41.4%), and asthenia with QW treatment (62.5%). Two patients treated Q3W (both 1000 mg) and three patients treated QW (120 mg, 2 patients; 180 mg, 1 patient) experienced partial response. Conclusions The MTD of BI 836880 was 720 mg Q3W and 180 mg QW. BI 836880 was generally manageable and demonstrated preliminary efficacy.This work was supported by Boehringer Ingelheim International GmbH. Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Hannah Simmons, MSc, of Ashfield MedComms, an Ashfield Health company and funded by Boehringer Ingelheim.ElsevierInstitut Català de la Salut[Le Tourneau C] Department of Drug Development and Innovation (D3i), Institut Curie, INSERM U900 Research Unit, Paris-Saclay University, Paris & Saint-Cloud, France. [Becker H, Fritsch R] Department of Medicine I (Hematology, Oncology and Stem Cell Transplantation), Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. [Claus R] Department of Medicine I (Hematology, Oncology and Stem Cell Transplantation), Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Medical Faculty Augsburg University, Augsburg, Germany. [Elez E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Ricci F] Department of Drug Development and Innovation (D3i), Institut Curie, INSERM U900 Research Unit, Paris-Saclay University, Paris & Saint-Cloud, France. [Tabernero J] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IOB-Quiron, Barcelona, SpainVall d'Hebron Barcelona Hospital Campus202320232022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/9661Scientiareponame:Scientia. Dipòsit d'Informació Digital del Departament de Salutinstname:Departament de Salut de la Generalitat de Catalunya (DS)InglésESMO Open;7(5)https://doi.org/10.1016/j.esmoop.2022.100576Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:scientiasalut.gencat.cat:11351/96612026-06-12T09:38:37Z
score 15,811543

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