Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
4
Advanced solid tumours
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
- 31 Oct 2025 → ongoing
- Decision date (initial)
- 2024-07-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511501-37-00
- EudraCT number
- 2022-000298-22
- WHO UTN
- U1111-1303-5359
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumours
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
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 26 | 4 |
| Rest of world
United Kingdom, United States, Japan
|
— | 74 | — |
Investigational sites
Hospital Clinico Universitario De Valencia
Oncology Department, Avenida Blasco Ibanez 17, 46010, Valencia
Vall D Hebron Institute Of Oncology
Oncology Department, Calle Natzaret 115, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
START Madrid-HM CIOCC Early Phase Program, Calle Ona 10, 28050, Madrid
Fundacion Instituto Valenciano De Oncologia
Servicio de Oncología, Calle Professor Beltran Baguena 8, 46009, 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 | 2023-02-24 | 2023-03-14 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-100239
- Halt date
- 2025-09-22
- Member states concerned
- Spain
- Publication date
- 2025-10-01
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- This trial is on temporary halt of new patient enrollment as it met the criteria stated in Section 3.1.1. of the clinical trial protocol as confirmed in discussion with the dose escalation committee.
- Follow-up measures
- Continue treatment of ongoing patients, no protocol modification.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-22 | Spain | Acceptable 2024-07-05
|
2024-07-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-11 | Spain | Acceptable 2025-02-10
|
2025-02-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-26 | Spain | 2025-04-14 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-26 | Spain | Acceptable 2025-07-09
|
2025-07-09 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-14 | Spain | Acceptable 2025-07-09
|
2025-11-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-08 | Spain | Acceptable | 2026-01-30 |