Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
70
Countries
2
Sites
3
colorectal carcinoma (CRC)
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
- 11 Jul 2025 → ongoing
- Decision date (initial)
- 2025-06-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519301-36-00
- WHO UTN
- U1111-1316-8363
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
colorectal carcinoma (CRC)
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
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Temporarily halted | 22 | 1 |
| Spain | Temporarily halted | 18 | 2 |
| Rest of world
United States
|
— | 30 | — |
Investigational sites
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Head Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
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 |
|---|---|---|---|---|---|
| Germany | 2025-07-11 | ||||
| Spain | 2025-07-31 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-93964
- Halt date
- 2025-07-31
- Member states concerned
- Germany
- Publication date
- 2025-12-12
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Follow-up measures
- Please see the DIL attached.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-93965
- Halt date
- 2025-07-31
- Member states concerned
- Spain
- Publication date
- 2025-12-12
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Follow-up measures
- Please see the DIL attached.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-14 | Germany | Acceptable 2025-06-16
|
2025-06-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-18 | Germany | Acceptable 2025-06-16
|
2025-07-18 |