Clinical trial • Phase I/II • Oncology
AVZO-021 for Advanced solid tumors
Phase I/II trial of AVZO-021 for Advanced solid tumors. 302 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I/II
Key dates
- Initial CTIS Submission Date
- 25-10-2024
- First CTIS Authorization Date
- 03-03-2025
Trial design
Phase I/II trial across 32 sites in Belgium, France, Germany and others.
- Target Sample Size
- 302
Eligibility
Recruits 302 Vulnerable population not selected (isVulnerablePopulationSelected=false).
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false)
Recruitment
- Planned Sample Size
- 302
- Recruitment Window Months
- 59
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 52
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-02-2025
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 19
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Gynaecological oncology
- Contact Person Name
- Stephanie Henry
- Contact Person Email
- stephanie.henry@chuuclnamur.uclouvain.be
- Site Name
- Antwerp University Hospital
- Department Name
- Gynaecological oncology
- Contact Person Name
- Konstantinos Papadimitriou
- Contact Person Email
- oncotrials@uza.be
- Site Name
- UZ Leuven
- Department Name
- Gynaecological oncology
- Contact Person Name
- Toon Van Gorp
- Contact Person Email
- toon.vangorp@uzleuven.be
- Site Name
- Cliniques universitaires Saint-Luc
- Department Name
- Gynaecological oncology
- Contact Person Name
- Jean-François Baurain
- Contact Person Email
- jean-francois.baurain@saintluc.uclouvain.be
France
- Earliest CTIS Part Ii Submission Date
- 03-02-2025
- Latest Decision Or Authorization Date
- 05-03-2025
- Processing Time Days
- 30
- Number Of Sites
- 7
- Number Of Participants
- 11
Sites
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Contact Person Name
- Arthur GERAUD-CREMIEUX
- Contact Person Email
- GeraudCremieuxa@ipc.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Jean-Yves BLAY
- Contact Person Email
- Jean-Yves.Blay@lyon.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Contact Person Name
- Mario CAMPONE
- Contact Person Email
- Mario.Campone@ico.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Department of Medecine
- Contact Person Name
- Alessandro VIANSONE
- Contact Person Email
- Alessandro.Viansone@gustaveroussy.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Oncology
- Contact Person Name
- Florence DALENC
- Contact Person Email
- Dalenc.Florence@iuct-oncopole.fr
- Site Name
- Institut Bergonié
- Department Name
- Medical Oncology
- Contact Person Name
- Antoine ITALIANO
- Contact Person Email
- A.Italiano@bordeaux.unicancer.fr
- Site Name
- Centre Georges François Leclerc
- Contact Person Name
- François GHIRINGHELLI
- Contact Person Email
- FGhiringhelli@cgfl.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 18-02-2025
- Latest Decision Or Authorization Date
- 06-03-2025
- Processing Time Days
- 16
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- University Hospital Düsseldorf
- Department Name
- Gynecological oncology
- Contact Person Name
- Eugen Ruckhaberle
- Contact Person Email
- Studienzentrale.Frauenklinik@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Gynecology
- Contact Person Name
- Peter Fasching
- Contact Person Email
- peter.fasching@uk-erlangen.de
- Site Name
- Uniklinikum Leipzig
- Department Name
- Gynecology
- Contact Person Name
- Bahriye Aktas
- Contact Person Email
- bahriye.aktas@medizin.uni-leipzig.de
- Site Name
- Universitätsklinikum Augsburg
- Department Name
- Gynacology
- Contact Person Name
- Nina Ditsch
- Contact Person Email
- simone.storck@uk-augsburg.de
Italy
- Earliest CTIS Part Ii Submission Date
- 20-12-2024
- Latest Decision Or Authorization Date
- 05-03-2025
- Processing Time Days
- 75
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
- Department Name
- Oncology
- Contact Person Name
- Vanesa Gregorc
- Contact Person Email
- vanesa.gregorc@ircc.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Medicina Intenra - SOD Clinica Oncologica
- Contact Person Name
- Rossana Berardi
- Contact Person Email
- r.berardi@univpm.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Oncology
- Contact Person Name
- Annalisa Fontana
- Contact Person Email
- fontana.annalisa@aou.mo.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Sviluppo Nuovi Farmaci per Terapie Innovative
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- Oncology Division
- Contact Person Name
- Alessandra Gennari
- Contact Person Email
- alessandra.gennari@med.uniupo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 13-02-2025
- Latest Decision Or Authorization Date
- 03-03-2025
- Processing Time Days
- 18
- Number Of Sites
- 12
- Number Of Participants
- 10
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Contact Person Name
- Eduardo Castanon Alvarez
- Contact Person Email
- ecastanon@unav.es
- Site Name
- Hospital Beata Maria Ana
- Department Name
- Medical Oncology
- Contact Person Name
- Javier Cortes Castan
- Contact Person Email
- javier.cortes@maj3.health
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Medical Oncology
- Contact Person Name
- Eduardo Castanon Alvarez
- Contact Person Email
- ecastanon@unav.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Contact Person Name
- Aitana Calvo Ferrandiz
- Contact Person Email
- aitanacalvo@hotmail.com
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Medical Oncology
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Contact Person Name
- Bernard Doger de Speville
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Contact Person Name
- Mafalda Oliveira Antunes de Melo
- Contact Person Email
- moliveira@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Alejandro Falcon Gonzalez
- Contact Person Email
- afalconglez@gmail.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical Oncology
- Contact Person Name
- Ramon Yarza Barrio
- Contact Person Email
- ramon.yarza@startmadrid.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Contact Person Name
- Eva Maria Ciruelos Gil
- Contact Person Email
- eva.ciruelos@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Medical Oncology
- Contact Person Name
- Jose Angel Garcia Saenz
- Contact Person Email
- jgsaenz@salud.madrid.org
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Medical Oncology
- Contact Person Name
- Angel Luis Guerrero Zotano
- Contact Person Email
- aguerrero@fivo.org
Sponsor
Primary sponsor
- Full Name
- Avenzo Therapeutics Inc.
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- AVZO-021
- First In Human
- Yes
- Combination Treatment
- Yes
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