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
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

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
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Jean-Yves BLAY
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
Site Name
Oncopole Claudius Regaud
Department Name
Oncology
Contact Person Name
Florence DALENC
Site Name
Institut Bergonié
Department Name
Medical Oncology
Contact Person Name
Antoine ITALIANO
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
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
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

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
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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