Clinical trial • Phase III • Oncology

DAK539 for Advanced malignant neoplasms | Hepatic impairment

Phase III trial of DAK539 for Advanced malignant neoplasms | Hepatic impairment. 24 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced malignant neoplasms | Hepatic impairment
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
28-11-2025
First CTIS Authorization Date
09-04-2026

Trial design

Phase III trial across 11 sites in France, Italy, Spain.

Target Sample Size
24

Eligibility

Recruits 24 Vulnerable population selected; no details on consent or assent handling provided in the record..

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

Recruitment

Planned Sample Size
24
Recruitment Window Months
27

Geography

Total Number Of Sites
11
Total Number Of Participants
19

France

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
18
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie Médicale
Contact Person Name
Amaury Daste
Contact Person Email
amaury.daste@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncologie Médicale
Contact Person Name
Mario Campone
Contact Person Email
mario.campone@ico.unicancer.fr

Italy

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
58
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
U.O Oncologia Medica
Contact Person Name
Gianluca Del Conte
Contact Person Email
delconte.gianluca@hsr.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Medical Oncology
Contact Person Name
Vanesa Gregorc
Contact Person Email
vanesa.gregorc@ircc.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it

Spain

Earliest CTIS Part Ii Submission Date
16-02-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
56
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Manuel Pedregal Trujillo
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Contact Person Name
Fabricio Racca Bussano
Contact Person Email
fracca@nextoncology.eu
Site Name
Hospital Hm Nou Delfos
Department Name
Oncology
Contact Person Name
Tatiana Hernandez Guerrero
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Emiliano Calvo Aller
Contact Person Email
emiliano.calvo@startmadrid.com

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
DAK539

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