Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
150
Countries
3
Sites
3
Advanced Solid Tumor
Key facts
- Sponsor
- Daiichi Sankyo Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Apr 2025 → ongoing
- Decision date (initial)
- 2025-02-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512058-11-00
- ClinicalTrials.gov
- NCT06644755
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Daiichi Sankyo Inc.
- Sponsor organisation
- Daiichi Sankyo Inc.
- Address
- 211 Mount Airy Road
- City
- Basking Ridge
- Postcode
- 07920-2311
- Country
- United States
Scientific contact point
- Organisation
- Daiichi Sankyo Inc.
- Contact name
- Clinical Trial Office
Public contact point
- Organisation
- Daiichi Sankyo Inc.
- Contact name
- Clinical Trial Office
Locations
3 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 8 | 1 |
| France | Ongoing, recruiting | 28 | 1 |
| Netherlands | Ongoing, recruiting | 9 | 1 |
| Rest of world
United States, Korea, Republic of
|
— | 105 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Clinical Research Unit, Department of Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
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 |
|---|---|---|---|---|---|
| Belgium | 2025-04-17 | 2025-04-22 | |||
| France | 2025-04-09 | 2025-06-25 | |||
| Netherlands | 2025-06-02 | 2025-07-08 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-22 | Belgium | Acceptable with conditions 2025-02-03
|
2025-02-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-26 | Belgium | Acceptable 2025-08-21
|
2025-08-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-10 | Belgium | Acceptable 2025-08-21
|
2025-10-10 |