Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
196
Countries
7
Sites
17
Advanced head and neck cancer
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Sep 2021 → ongoing
- Decision date (initial)
- 2024-03-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-510307-22-00
- EudraCT number
- 2021-000234-34
- WHO UTN
- U1111-1310-6376
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced head and neck cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Locations
7 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 23 | 3 |
| Czechia | Ended | 2 | 1 |
| France | Ongoing, recruitment ended | 4 | 3 |
| Germany | Ongoing, recruitment ended | 6 | 3 |
| Italy | Ended | 5 | 1 |
| Netherlands | Ongoing, recruitment ended | 30 | 2 |
| Spain | Ongoing, recruitment ended | 41 | 4 |
| Rest of world
Mexico, Israel, Korea, Republic of, Japan, China, Australia, United States, Brazil
|
— | 85 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Unité d'Oncologie Médicale, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
UNICCRA Research Unit Oncology, Drie Eikenstraat 655, 2650, Edegem
Algemeen Ziekenhuis Groeninge
Oncologisch centrum, President Kennedylaan 4, 8500, Kortrijk
Masarykuv Onkologicky Ustav
Comprehensive Cancer Care Department, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Centre Hospitalier Universitaire De Bordeaux
Service d’Oncologie Médicale, 1 Rue Jean Burguet, 33000, Bordeaux
Centr Georges Francois Leclerc
Unité de Phase Précoce, 1 Rue Professeur Marion, 21000, Dijon
Institut De Cancerologie De L Ouest
Service d'Oncologie Médicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Klinik für Hämatologie, Onkologie, Stammzelltransplantation und Palliativmedizin, Kriegsbergstrasse 60, Mitte, Stuttgart
Martin-Luther-Universitaet Halle-Wittenberg
Universitätsmedizin Halle, Klinik für Innere Medizin IV, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Medical Center - University Of Freiburg
Klinik für Tumorbiologie und Innere Medizin I, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Struttura Complessa Oncologia Medica Melanoma, Via Mariano Semmola 52, 80131, Naples
Amsterdam UMC Stichting
Radiology & Nuclear Medicine, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Interne Oncologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Institut Catala D'oncologia
Institut Català d'oncologia, Carretera Canyet S/n, 08916, Badalona
Vall D Hebron Institute Of Oncology
Early Drug Development Unit-UITM, Calle Natzaret 115, 08035, Barcelona
Clinica Universidad De Navarra
Unidad central de Ensayos Clínicos, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinico San Carlos
Servicio de Oncología Médica, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
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 |
|---|---|---|---|---|---|
| Belgium | 2021-09-28 | 2025-12-08 | 2021-10-18 | 2025-12-08 | |
| Czechia | 2025-12-09 | ||||
| France | 2025-06-13 | 2025-07-23 | 2026-01-12 | ||
| Germany | 2025-06-17 | 2025-08-12 | 2026-01-12 | ||
| Italy | 2023-02-16 | 2023-05-16 | 2023-11-07 | ||
| Netherlands | 2022-08-17 | 2022-11-25 | 2026-01-12 | ||
| Spain | 2021-09-24 | 2021-11-02 | 2026-01-12 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Spain | Acceptable 2024-03-11
|
2024-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-27 | Spain | Acceptable 2024-09-02
|
2024-09-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-30 | Spain | Acceptable 2025-01-17
|
2025-01-17 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-01-27 | 2025-04-22 | ||
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-01-27 | Acceptable 2025-01-17
|
2025-04-10 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-01-27 | Acceptable 2025-01-17
|
2025-04-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-11 | Acceptable | 2025-04-10 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-30 | Spain | Acceptable 2025-07-28
|
2025-07-29 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-08 | Spain | Acceptable 2025-07-28
|
2025-10-08 |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-03 | Spain | Acceptable 2026-04-01
|
2026-04-02 |