Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
98
Countries
3
Sites
4
Advanced (unresectable or metastatic) human epidermal growth receptor 2 (HER2)-expressing/HER2-mutated solid tumors
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
- 11 Jan 2024 → ongoing
- Decision date (initial)
- 2024-08-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503965-48-00
- ClinicalTrials.gov
- NCT05765851
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced (unresectable or metastatic) human epidermal growth receptor 2 (HER2)-expressing/HER2-mutated solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10065430 | HER2 positive breast cancer | 100000004864 |
| 20.1 | PT | 10055113 | Breast cancer metastatic | 100000004864 |
| 21.1 | PT | 10028980 | Neoplasm | 100000004864 |
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 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 · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 6 | 1 |
| France | Ongoing, recruiting | 10 | 2 |
| Spain | Ongoing, recruiting | 20 | 1 |
| Rest of world
Japan, Canada, United States
|
— | 62 | — |
Investigational sites
Institut Jules Bordet
Research, Medical oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Institut Universitaire Du Cancer Toulouse-Oncopole
Service d'oncologie médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Leon Berard
Service oncologie médicale, 28 Rue Laennec, 69008, Lyon
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 | 2024-01-11 | 2024-01-11 | |||
| Spain | 2024-04-12 | 2024-04-12 | |||
| Belgium |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-26 | Spain | Acceptable 2023-10-05
|
2023-10-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-09 | Spain | Acceptable 2023-10-05
|
2023-11-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-17 | Spain | Acceptable 2024-02-14
|
2024-02-14 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-04-24 | Acceptable 2024-02-14
|
2024-06-25 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-19 | Acceptable | 2024-08-20 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-23 | Spain | Acceptable 2024-11-25
|
2024-11-27 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-09 | Spain | Acceptable 2025-05-13
|
2025-05-21 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-28 | Spain | Acceptable 2026-01-27
|
2026-01-28 |