Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
40
Countries
1
Sites
2
Advanced or Metastatic Adrenocortical Carcinoma (ACC), Metastatic Castration-resistant Prostate Cancer (CRPC)
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
- 19 Feb 2026 → ongoing
- Decision date (initial)
- 2025-12-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Adrenocortical Carcinoma (ACC), Metastatic Castration-resistant Prostate Cancer (CRPC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10062904 | Hormone-refractory prostate cancer | 100000004864 |
| 21.0 | PT | 10036911 | Prostate cancer recurrent | 100000004864 |
| 21.1 | LLT | 10002223 | Anaplastic adrenocortical carcinoma | 10029104 |
| 24.1 | LLT | 10085680 | Advanced prostate cancer | 100000004848 |
| 24.1 | LLT | 10085680 | Advanced prostate cancer | 100000004848 |
| 20.0 | PT | 10001388 | Adrenocortical carcinoma | 100000004864 |
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
| 21.1 | LLT | 10012788 | Differentiated adrenocortical carcinoma | 10029104 |
| 27.0 | LLT | 10086830 | Hormone-refractory prostate cancer metastatic | 100000004848 |
| 27.0 | LLT | 10086830 | Hormone-refractory prostate cancer metastatic | 100000004848 |
| 20.0 | LLT | 10007113 | Cancer of prostate | 10029104 |
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 24.1 | LLT | 10085679 | Locally advanced prostate cancer | 100000004848 |
| 26.1 | PT | 10062904 | Hormone-refractory prostate cancer | 100000004864 |
| 27.0 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
| 24.1 | LLT | 10085679 | Locally advanced prostate cancer | 100000004848 |
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
| 20.0 | LLT | 10007113 | Cancer of prostate | 10029104 |
| 21.0 | PT | 10036911 | Prostate cancer recurrent | 100000004864 |
| 27.0 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
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
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 15 | 2 |
| Rest of world
United States, United Kingdom
|
— | 25 | — |
Investigational sites
Oncopole Claudius Regaud
Oncologie Médical, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Oscar Lambret
Oncologie Médical, 3 Rue Frederic Combemale, 59000, Lille
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 | 2026-02-19 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-17 | France | Acceptable 2025-12-03
|
2025-12-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-10 | France | Acceptable | 2026-01-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-23 | France | Acceptable | 2026-01-23 |