Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
114
Countries
8
Sites
24
Head and neck squamous cell carcinoma
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Nov 2025 → ongoing
- Decision date (initial)
- 2025-05-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517091-38-00
- WHO UTN
- U1111-1312-0435
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Head and neck squamous cell carcinoma
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
Locations
8 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruiting | 8 | 1 |
| France | Ongoing, recruiting | 5 | 4 |
| Germany | Ongoing, recruiting | 6 | 4 |
| Hungary | Ongoing, recruiting | 4 | 3 |
| Italy | Authorised, recruiting | 6 | 5 |
| Poland | Authorised, recruiting | 5 | 2 |
| Romania | Ongoing, recruiting | 16 | 2 |
| Spain | Ongoing, recruiting | 5 | 3 |
| Rest of world
Taiwan, Brazil, United States, Korea, Republic of, Moldova, Republic of, Thailand, Mexico, Georgia, Australia, Switzerland, Singapore, Turkey, United Kingdom, Japan
|
— | 59 | — |
Investigational sites
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department of Medical Oncology, Bulevard Bilgariya 104, 1404, Sofiya
Centre Leon Berard
Service d'Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Oscar Lambret
DRCI, 3 Rue Frederic Combemale, 59000, Lille
Centre Hospitalier Regional De Marseille
Unité de Phase I Oncologie labélisée CLIP, 264 Rue Saint Pierre, 13005, Marseille
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Staedtisches Klinikum Braunschweig gGmbH
Medizinische Klinik II, Celler Strasse 38, 38114, Brunswick
Universitaetsklinikum Jena KöR
HNO-Klinik, Am Klinikum 1, Lobeda, Jena
Universitaet Leipzig
Klinik und Poliklinik für HNO-Heilkunde und Plastische Operationen, Liebigstrasse 12, Zentrum-Suedost, Leipzig
Universitaetsklinikum Ulm AöR
für HNO-Heilkunde, Albert-Einstein-Allee 23, Eselsberg, Ulm
Semmelweis University
Internal Medicine and Oncology Clinic, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Clinexpert Kft.
Bugat Pal Hospital, Dozsa Gyorgy Utca 15, 3200, Gyongyos
Orszagos Onkologiai Intezet
Department of Thoracic and Abdominal Tumors and Clinical Pharmacology, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
S.C. di Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Centro Ricerche Cliniche Di Verona S.r.l.
Centro Ricerche Cliniche di Verona - Policlinico G.B. Rossi, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione IRCCS Istituto Nazionale Dei Tumori
Dipartimento di Medicina-SS Trattamento Tumori Testa e Collo, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
UOC Oncologia, Via Sergio Pansini 5, 80131, Naples
I.F.O. Istituti Fisioterapici Ospitalieri
Divisione Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oncology, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology clinic clinical outpatient clinic, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Clinico Universitario De Valencia
Servicio de Oncología Médica, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Unidad de Investigación en Terapia Molecular (UITM), Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Victoria
xxxx, Campus De Teatinos Sn, Puerto De La Torre, Malaga
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 |
|---|---|---|---|---|---|
| Bulgaria | 2026-01-28 | ||||
| France | 2025-12-02 | 2025-12-19 | |||
| Germany | 2025-11-25 | 2025-12-18 | |||
| Hungary | 2026-03-24 | 2026-03-31 | |||
| Italy | 2026-03-20 | ||||
| Poland | 2026-03-30 | ||||
| Romania | 2025-12-23 | 2026-01-15 | |||
| Spain | 2026-01-09 | 2026-04-10 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-31 | Spain | Acceptable with conditions 2025-05-22
|
2025-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-12 | Spain | Acceptable 2025-11-17
|
2025-11-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-25 | Acceptable 2025-11-17
|
2025-11-25 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-28 | Spain | Acceptable 2026-02-10
|
2026-02-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-05 | Acceptable | 2026-04-20 |