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
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Pneumologie Innenstadt und Thorakale Onkologie
- Contact Person Name
- Amanda Tufman
- Contact Person Email
- amanda.tufman@med.uni-muenchen.de
- 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
- Contact Person Email
- cristina.smolenschi@gustaveroussy.fr
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
- Contact Person Email
- marinaelena.cazzaniga@irccs-sangerardo.it
- 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
- Contact Person Email
- alejandro.falcon.sspa@juntadeandalucia.es
- 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
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- 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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