Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
3
unresectable advanced or metastatic solid 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
- 30 Apr 2026 → ongoing
- Decision date (initial)
- 2026-04-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522953-21-00
- WHO UTN
- U1111-1328-0914
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
unresectable advanced or metastatic solid 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
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 12 | 3 |
| Rest of world
Japan, Australia, United States
|
— | 48 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Servicio oncología y hematología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Unidad central de Ensayos Clínicos, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Clinico Universitario De Valencia
Servicio de Hematologia y Oncologia, INCLIVA. Edificio Maternidad., Avenida Blasco Ibanez 17, 46010, Valencia
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 |
|---|---|---|---|---|---|
| Spain | 2026-04-30 | 2026-05-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-09 | Spain | Acceptable 2026-04-07
|
2026-04-13 |