Clinical trial • Phase I • Oncology

ZN-A-1041 for HER2-positive advanced solid tumours|Locally advanced breast cancer

Phase I trial of ZN-A-1041 for HER2-positive advanced solid tumours|Locally advanced breast cancer. 80 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-positive advanced solid tumours|Locally advanced breast cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
15-01-2024
First CTIS Authorization Date
23-04-2024

Trial design

Phase I trial in France, Spain, Italy.

Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
80

Eligibility

Recruits 80 Vulnerable population selected; no further details on consent or assent handling provided in the available data..

Vulnerable Population
Vulnerable population selected; no further details on consent or assent handling provided in the available data.

Recruitment

Planned Sample Size
80
Recruitment Window Months
30

Geography

Total Number Of Sites
25
Total Number Of Participants
34

France

Earliest CTIS Part Ii Submission Date
10-04-2024
Latest Decision Or Authorization Date
12-09-2025
Processing Time Days
520
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Institut Paoli-Calmettes
Contact Person Name
Anthony GONCALVES
Contact Person Email
goncalvesa@ipc.unicancer.fr
Site Name
Centre Oscar Lambret
Contact Person Name
Claire CHEYMOL
Contact Person Email
c-cheymol@o-lambret.fr
Site Name
Institut Gustave Roussy
Contact Person Name
Alessandro VIANSONE
Contact Person Email
ALESSANDRO.VIANSONE@gustaveroussy
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Contact Person Name
Florence DALENC
Site Name
Centre Leon Berard
Contact Person Name
Thomas BACHELOT
Site Name
Institut De Cancerologie De L Ouest
Contact Person Name
Mario CAMPONE
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Centr Georges Francois Leclerc
Contact Person Name
Isabelle DESMOULINS
Contact Person Email
idesmoulins@cgfl.fr

Spain

Earliest CTIS Part Ii Submission Date
27-03-2024
Latest Decision Or Authorization Date
19-09-2025
Processing Time Days
541
Number Of Sites
13
Number Of Participants
14

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Manuel Ruiz Borrego
Contact Person Email
ruizsabater@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Contact Person Name
Rafael López López
Contact Person Email
rafael.lopez.lopez@sergas.es
Site Name
Hospital Universitario 12 De Octubre
Contact Person Name
Manuel Alva Bianchi
Contact Person Email
malvabianchi@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Contact Person Name
Ángel Luis Guerrero Zotano
Contact Person Email
aguerrero@fivo.org
Site Name
Hospital Universitari Vall D Hebron
Contact Person Name
Cristina Saura Manich
Contact Person Email
csaura@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Contact Person Name
Noelia Martínez Jáñez
Contact Person Email
mjnoelia@hotmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
José Ángel García Sáenz
Contact Person Email
jgsaenz@salud.madrid.org
Site Name
Hospital Universitario Virgen De La Macarena
Contact Person Name
Luis De La Cruz Merino
Contact Person Email
ldelacruzmerino@gmail.com
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Medical Oncology
Contact Person Name
José Manuel Pérez García
Site Name
Hospital Clinic De Barcelona
Contact Person Name
Iván Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Contact Person Name
Maria Gion Cortes
Contact Person Email
mariagion@gmail.com
Site Name
Hospital Universitario De Jaen
Department Name
Medical Oncology
Contact Person Name
Pedro Sánchez Rovira
Contact Person Email
oncopsr@yahoo.es
Site Name
Hospital Clinico Universitario De Valencia
Contact Person Name
Begoña Bermejo de las Heras
Contact Person Email
begobermejo@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
22-04-2025
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
162
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Phase 1 Unit
Contact Person Name
Gennaro Daniele
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Centro Ricerca Fase 1
Contact Person Name
Marina Elena Cazzaniga
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
New Drug Development for Innovative Therapies (Sviluppo di Nuovi Farmaci per Terapie Innovative)
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Struttura Complessa di Oncologia
Contact Person Name
Alberto Alberto Zambelli
Contact Person Email
azambelli@asst-pg23.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Struttura Complessa di Oncologia Medica
Contact Person Name
Antonino Musolino
Contact Person Email
antonino.musolino@irst.emr.it

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
ZN-A-1041
Combination Treatment
Yes

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