Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
81
Countries
1
Sites
2
Advanced or metastatic solid tumors
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-524334-26-01
- WHO UTN
- U1111-1330-3304
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 27.0 | PT | 10057529 | Ovarian cancer metastatic | 100000004864 |
| 27.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
| 21.0 | LLT | 10056267 | Gastroesophageal cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 15 | 2 |
| Rest of world
Japan, United States
|
— | 66 | — |
Investigational sites
Rigshospitalet
Department of Oncology, Rigshospitalet, Copenhagen, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Phase 1 Unit, Dept. of Oncology, Odense University Hospital, J. B. Winsloews Vej 4, 5000, Odense C
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 |
|---|---|---|---|---|---|
| Denmark | 2026-03-26 | 2026-03-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-09 | Denmark | Acceptable 2026-02-26
|
2026-02-26 |