Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
76
Countries
2
Sites
8
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
- 25 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516625-31-00
- ClinicalTrials.gov
- NCT07015697
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
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 4 |
| Spain | Ongoing, recruiting | 15 | 4 |
| Rest of world
Taiwan, Japan, Brazil, United States, Korea, Republic of
|
— | 51 | — |
Investigational sites
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centr Georges Francois Leclerc
Early Phase Unit - Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Francois Baclesse
Service de Pathologie Mammaire, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| France | 2026-01-22 | 2026-05-13 | |||
| Spain | 2025-11-25 | 2026-01-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-10 | Spain | Acceptable 2025-10-30
|
2025-10-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-20 | Spain | Acceptable 2026-04-13
|
2026-04-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-22 | Acceptable 2026-04-13
|
2026-04-22 |