Clinical trial • Phase I • Oncology

ABBV-400 for Locally advanced or metastatic solid tumors

Phase I trial of ABBV-400 for Locally advanced or metastatic solid tumors. open-label. 160 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced or metastatic solid tumors
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
24-04-2024
First CTIS Authorization Date
30-07-2024

Trial design

open-label Phase I trial across 15 sites in France, Spain.

Open Label
Yes
Target Sample Size
160
Trial Duration For Participant
1460

Eligibility

Recruits 160 No vulnerable populations selected; consent/assent handling not specified.

Vulnerable Population
No vulnerable populations selected; consent/assent handling not specified

Recruitment

Planned Sample Size
160
Recruitment Window Months
23

Geography

Total Number Of Sites
15
Total Number Of Participants
60

France

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
29-07-2024
Processing Time Days
28
Number Of Sites
6
Number Of Participants
24

Sites

Site Name
Centr Georges Francois Leclerc
Department Name
403 : Medical Oncology
Principal Investigator Name
Francois Ghiringhelli
Principal Investigator Email
fghiringhelli@cgfl.fr
Contact Person Name
Francois Ghiringhelli
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
402 : Medical Oncology
Principal Investigator Name
Judith Raimbourg
Principal Investigator Email
judith.raimbourg@ico.unicancer.fr
Contact Person Name
Judith Raimbourg
Site Name
Institut Bergonie
Department Name
404 : Medical Oncology
Principal Investigator Name
Sophie COUSIN
Principal Investigator Email
s.cousin@bordeaux.unicancer.fr
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Institut Curie
Department Name
405 : Department of Drug Development and Innovation
Principal Investigator Name
Marie-Paule Sablin
Principal Investigator Email
mariepaule.sablin@curie.fr
Contact Person Name
Marie-Paule Sablin
Contact Person Email
mariepaule.sablin@curie.fr
Site Name
Centre Leon Berard
Department Name
401 : Department of Medical Oncology
Principal Investigator Name
Aurelie Swalduz
Principal Investigator Email
aurelie.swalduz@lyon.unicancer.fr
Contact Person Name
Aurelie Swalduz
Site Name
Institut Gustave Roussy
Department Name
400 : DITEP Drug Development Department
Principal Investigator Name
Antoine Hollebecque
Principal Investigator Email
antoine.hollebecque@gustaveroussy.fr
Contact Person Name
Antoine Hollebecque

Spain

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
558
Number Of Sites
9
Number Of Participants
36

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
606 : Oncología Médica
Principal Investigator Name
Elena Garralda Cabanas
Principal Investigator Email
egarralda@vhio.net
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
605 : Oncología Medica
Principal Investigator Name
Ana Landa Magdalena
Principal Investigator Email
alandam@unav.es
Contact Person Name
Ana Landa Magdalena
Contact Person Email
alandam@unav.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
610 : Oncología
Principal Investigator Name
Ana Landa Magdalena
Principal Investigator Email
alandam@unav.es
Contact Person Name
Ana Landa Magdalena
Contact Person Email
alandam@unav.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
600 : Oncología
Principal Investigator Name
Bernard Gaston Doger De Speville Uribe
Principal Investigator Email
bernard.doger@startmadrid.com
Contact Person Name
Bernard Gaston Doger De Speville Uribe
Contact Person Email
bernard.doger@startmadrid.com
Site Name
Institut Catala D'oncologia
Department Name
609 : Oncología Médica
Principal Investigator Name
Cinta Hierro Carbó
Principal Investigator Email
chierro@iconcologia.net
Contact Person Name
Cinta Hierro Carbó
Contact Person Email
chierro@iconcologia.net
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
602 : Oncología Médica
Principal Investigator Name
Juan Jose Soto
Principal Investigator Email
juanj.soto@startresearch.com
Contact Person Name
Juan Jose Soto
Contact Person Email
juanj.soto@startresearch.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
607 : Neumología
Principal Investigator Name
Aitana Calvo Ferrándiz
Principal Investigator Email
pilaraitanacalvo@salud.madrid.org
Contact Person Name
Aitana Calvo Ferrándiz
Site Name
Hospital Hm Nou Delfos
Department Name
608 : Oncología
Principal Investigator Name
Tatiana Hernández Guerrero
Principal Investigator Email
tatiana.hernandez@start-barcelona.com
Contact Person Name
Tatiana Hernández Guerrero
Site Name
Hospital Universitario (additional site)

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
ABBV-400

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