Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
27
Countries
2
Sites
5
Advanced solid tumors
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
- 16 Oct 2023 → 11 Apr 2025
- Decision date (initial)
- 2023-09-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502125-17-00
- WHO UTN
- U1111-1291-2873
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049516 | Malignant tumor | 10029104 |
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
- City
- Sant Cugat Del Valles
- Postcode
- 08174
- Country
- Spain
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 12 | 4 |
| Sweden | Ended | 2 | 1 |
| Rest of world
United States, Canada
|
— | 13 | — |
Investigational sites
Hospital Clinic De Barcelona
Servicio de Oncología Médica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario 12 De Octubre
Servicio de Oncología Médica, Bloque D, Avenida De Cordoba S/n, Madrid
Fundacion Instituto Valenciano De Oncologia
Servicio de Oncología Médica, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Quironsalud Barcelona
Next Oncology Barcelona IOB, Placa D'alfonso Comin 5-7, 08023, Barcelona
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 | 2023-10-17 | 2023-11-22 | 2024-08-14 | ||
| Sweden | 2023-10-16 | 2023-11-10 | 2024-08-14 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-42538
- Halt date
- 2024-08-14
- Member states concerned
- Sweden
- Publication date
- 2024-08-27
- Reason
- Study management related, Sponsor decision
- Explanation
- The protocol defined criteria for enrolment hold have not been met. The decision of temporary hold is based on the recommendation of the Dose Escalation Committee and to perform an analysis of the data for the first ten patients treated with BI 1821736.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-42539
- Halt date
- 2024-08-14
- Member states concerned
- Spain
- Publication date
- 2024-08-27
- Reason
- Sponsor decision, Study management related
- Explanation
- The protocol defined criteria for enrolment hold have not been met. The decision of temporary hold is based on the recommendation of the Dose Escalation Committee and to perform an analysis of the data for the first ten patients treated with BI 1821736.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-30 | Spain | Acceptable 2023-09-04
|
2023-09-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-18 | Spain | Acceptable 2023-09-04
|
2024-01-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-19 | Spain | Acceptable 2023-09-04
|
2024-04-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-02 | Spain | Acceptable | 2024-11-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-24 | Spain | Acceptable 2025-06-09
|
2025-06-09 |