Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
16
Countries
2
Sites
3
Advanced 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
- 24 Mar 2025 → ongoing
- Decision date (initial)
- 2024-11-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515518-41-00
- WHO UTN
- U1111-1308-9700
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 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
- 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
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruiting | 8 | 1 |
| Spain | Ongoing, recruiting | 8 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Magyarorszag
PRA Klinikai Farmakológiai Vizsgálóhely, Rottenbiller Utca 13, 1077, Budapest
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 |
|---|---|---|---|---|---|
| Hungary | 2025-03-24 | 2025-03-24 | |||
| Spain | 2026-03-06 | 2026-03-06 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-20 | Hungary | Acceptable 2024-11-18
|
2024-11-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-05 | Hungary | Acceptable 2025-03-12
|
2025-03-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-16 | Hungary | Acceptable 2025-06-03
|
2025-07-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-29 | Hungary | Acceptable | 2025-09-01 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-10-23 | Acceptable 2024-11-18
|
2026-02-02 |