Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
69
Countries
1
Sites
2
Advanced solid tumors
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Sep 2024 → 26 Sep 2025
- Decision date (initial)
- 2024-08-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-510998-26-00
- ClinicalTrials.gov
- NCT05858164
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 7 | 2 |
| Rest of world
Australia, China, United States, Israel, Korea, Republic of
|
— | 62 | — |
Investigational sites
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 | 2024-09-18 | 2025-09-22 | 2024-09-23 | 2025-04-22 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Spain | Acceptable with conditions 2024-08-20
|
2024-08-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-21 | Spain | Acceptable with conditions 2024-08-20
|
2024-08-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-30 | Spain | Acceptable 2024-12-04
|
2024-12-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-20 | Spain | Acceptable 2025-03-14
|
2025-03-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-16 | Spain | Acceptable 2025-05-26
|
2025-05-28 |