Clinical trial • Phase I • Oncology

ABBV-706 for Advanced solid tumors

Phase I trial of ABBV-706 for Advanced solid tumors. 250 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumors
Trial Stage
Phase I
Drug Modality
Other | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
03-10-2023
First CTIS Authorization Date
06-02-2024

Trial design

Phase I trial in Germany, France, Italy and others.

Target Sample Size
250

Eligibility

Recruits 250 Vulnerable population selected; no details provided on consent or assent handling..

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

Recruitment

Planned Sample Size
250
Recruitment Window Months
44

Geography

Total Number Of Sites
26
Total Number Of Participants
158

Germany

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
737
Number Of Sites
3
Number Of Participants
40

Sites

Site Name
Technische Universitat Dresden
Department Name
Medizinische Klinik I
Contact Person Name
Martin Wermke
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Pneumologie Innenstadt und Thorakale Onkologie
Contact Person Name
Amanda Tufman
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Hämatologie und Onkologie
Contact Person Name
Peter Brossart
Contact Person Email
peter.brossart@ukb.uni-bonn.de

France

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
742
Number Of Sites
3
Number Of Participants
35

Sites

Site Name
Institut Bergonie
Department Name
9450:Oncologie Médicale
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
9452:Oncologie Medicale
Contact Person Name
Diego Tosi
Contact Person Email
diego.tosi@icm.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
9451:Département d’Innovation Thérapeutique et d’Essais Précoces (DITEP)
Contact Person Name
Cristina SMOLENSCHI

Italy

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
03-06-2025
Processing Time Days
498
Number Of Sites
9
Number Of Participants
50

Sites

Site Name
Casa Sollievo Della Sofferenza
Department Name
Oncologia
Contact Person Name
Evaristo Maiello
Contact Person Email
e.maiello@operapadrepio.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
U.O. Oncologia Medica e dei Tumori Immuno-correlati
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncologia Medica
Contact Person Name
Stefania Salvagni
Contact Person Email
stefania.salvagni@aosp.bo.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Sperimentazioni Cliniche
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
U.O.C. Centro di ricerca di Fase I
Contact Person Name
Marinaelena Cazzaniga
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Oncologia Medica 2
Contact Person Name
Lorenza Landi
Contact Person Email
landi.lorenza@gmail.com
Site Name
Humanitas Mirasole S.p.A.
Department Name
UO Oncologia Medica ed Ematologia
Contact Person Name
Matteo Simonelli
Contact Person Email
matteo.simonelli@hunimed.eu
Site Name
European Institute Of Oncology S.r.l.
Department Name
Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
Immunoterapia Oncologica
Contact Person Name
Michele Maio
Contact Person Email
mmaiocro@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
10-01-2024
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
751
Number Of Sites
11
Number Of Participants
33

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
9405:Oncología
Contact Person Name
Pablo Gajate Borau
Contact Person Email
pgajate@salud.madrid.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
9403:Oncología
Contact Person Name
Alejandro Falcón González
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
9400:Oncología Médica
Contact Person Name
Emiliano Calvo Aller
Contact Person Email
emiliano.calvo@startmadrid.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
9402:Oncología Médica
Contact Person Name
Maria Vieito Villar
Contact Person Email
mvieito@vhio.net
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
9408:Oncology
Contact Person Name
David Lorente Estellés
Contact Person Email
dlorente@fivo.org
Site Name
Hospital Hm Nou Delfos
Department Name
9410:Oncología
Contact Person Name
Tatiana Hernández Guerrero
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
9406:Oncologia
Contact Person Name
Jose Maria Mazarico Gallego
Contact Person Email
jmmazarico@mutuaterrassa.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
9401:Oncología Médica
Contact Person Name
Luis Paz-Ares Rodríguez
Contact Person Email
Lpazaresr@Seom.Org
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
9407:Oncología Médica
Contact Person Name
Georgia Anguera
Contact Person Email
ganguera@santpau.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
9404:Oncologia Medica y Hematologia
Contact Person Name
Valentina Gambardella
Contact Person Email
vgambardella@incliva.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
9409:Oncología
Contact Person Name
Bernard Gaston Doger De Speville Uribe
Contact Person Email
bernard.doger@startmadrid.com

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-706
Active Substance
ABBV-706
Modality
Other
First In Human
Yes
Investigational Product Name
budigalimab (ABBV-181)
Active Substance
budigalimab
Modality
Monoclonal antibody
Investigational Product Name
carboplatin
Active Substance
carboplatin
Modality
Small molecule
Investigational Product Name
cisplatin
Active Substance
cisplatin
Modality
Small molecule
Combination Treatment
Yes

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