Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
408
Countries
4
Sites
26
Advanced solid tumors
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Apr 2024 → ongoing
- Decision date (initial)
- 2024-02-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Mainzer Strasse 81
- City
- Wiesbaden
- Postcode
- 65189
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
4 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 35 | 3 |
| Germany | Ongoing, recruitment ended | 40 | 3 |
| Italy | Ended | 50 | 9 |
| Spain | Ongoing, recruitment ended | 33 | 11 |
| Rest of world
China, Japan, United States, Israel, Australia, Korea, Republic of
|
— | 250 | — |
Investigational sites
Institut Regional Du Cancer De Montpellier
9452:Oncologie Medicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Bergonie
9450:Oncologie Médicale, 229 Cours De L Argonne, 33000, Bordeaux
Institut Gustave Roussy
9451:Département d’Innovation Thérapeutique et d’Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Technische Universitat Dresden
Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum der Universitaet Muenchen AöR
Pneumologie Innenstadt und Thorakale Onkologie, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Bonn AöR
Hämatologie und Onkologie, Venusberg-Campus 1, Venusberg, Bonn
Casa Sollievo Della Sofferenza
Oncologia, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Sperimentazioni Cliniche, Via Mariano Semmola 52, 80131, Naples
European Institute Of Oncology S.r.l.
Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione IRCCS San Gerardo Dei Tintori
U.O.C. Centro di ricerca di Fase I, Via Giovanni Battista Pergolesi 33, 20900, Monza
I.F.O. Istituti Fisioterapici Ospitalieri
UOC Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Centro Di Riferimento Oncologico Di Aviano
U.O. Oncologia Medica e dei Tumori Immuno-correlati, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Universitaria Senese
Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncologia Medica, Via Pietro Albertoni 15, 40138, Bologna
Humanitas Mirasole S.p.A.
UO Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Hospital Clinico Universitario De Valencia
9404:Oncologia Médica y Hematologia, Avenida Blasco Ibanez 17, 46010, Valencia
Fundacion Instituto Valenciano De Oncologia
9408:Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario 12 De Octubre
9401:Oncología Médica, Bloque D, Avenida De Cordoba Sn, Madrid
Fundacio Assistencial De Mutua De Terrassa Fpc
9406:Oncologia, Calle De San Antonio No 32, 08221, Terrassa
Hospital Universitario Fundacion Jimenez Diaz
9409:Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital De La Santa Creu I Sant Pau
9407:Oncología Médica, Carrer De San Quinti 89, 08041, Barcelona
Hospital Hm Nou Delfos
9410:Oncología, Avinguda De Vallcarca 151, 08023, Barcelona
University Hospital Virgen Del Rocio S.L.
9403:Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Hm Sanchinarro
9400:Oncología Médica, Calle Ona 10, 28050, Madrid
Hospital Universitario Ramon Y Cajal
9405:Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
9402:Oncología Médica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-08-09 | 2025-11-06 | 2024-11-13 | 2025-07-07 | |
| Germany | 2024-05-13 | 2024-06-06 | 2025-07-07 | ||
| Italy | 2024-09-16 | ||||
| Spain | 2024-04-03 | 2024-04-26 | 2025-07-07 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-03 | Italy | Acceptable 2024-02-05
|
2024-02-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-29 | Italy | Acceptable 2024-06-25
|
2024-06-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-06 | Acceptable | 2024-09-09 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-06 | Acceptable | 2024-09-05 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-06 | Acceptable | 2025-01-23 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-13 | Acceptable | 2025-01-16 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-19 | Acceptable | 2025-02-12 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-23 | Italy | Acceptable | 2025-03-20 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-03-31 | Italy | Acceptable 2025-06-03
|
2025-06-03 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-11-20 | Acceptable 2026-01-27
|
2026-01-28 |