Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
79
Countries
3
Sites
4
Advanced Solid Tumors
Key facts
- Sponsor
- Daiichi Sankyo Co. Ltd., Daiichi Sankyo Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 29 Jul 2025
- Decision date (initial)
- 2025-04-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517984-21-00
- ClinicalTrials.gov
- NCT06074705
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 | PT | 10028997 | Neoplasm malignant | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Daiichi Sankyo Co. Ltd.
- Sponsor organisation
- Daiichi Sankyo Co. Ltd.
- Address
- 3 Chome 5-1
- City
- Chuo
- Postcode
- 103-8426
- Country
- Japan
Scientific contact point
- Organisation
- Daiichi Sankyo Co. Ltd.
- Contact name
- Clinical Trial Office
Public contact point
- Organisation
- Daiichi Sankyo Co. Ltd.
- Contact name
- Clinical Trial Office
Daiichi Sankyo Co. Ltd.
- Sponsor organisation
- Daiichi Sankyo Co. Ltd.
- Address
- 3 Chome 5-1
- City
- Chuo
- Postcode
- 103-8426
- Country
- Japan
Locations
3 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 4 | 1 |
| France | Ended | 10 | 2 |
| Spain | Ended | 5 | 1 |
| Rest of world
Japan, United States
|
— | 60 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-10 | Spain | Acceptable 2025-04-25
|
2025-04-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-01 | Spain | Acceptable 2025-04-25
|
2025-07-01 |