Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
125
Countries
2
Sites
3
Advanced Clear Cell Renal Cell Carcinoma
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
- 25 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522543-18-00
- WHO UTN
- U1111-1323-5879
- ClinicalTrials.gov
- NCT07195682
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Clear Cell Renal Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10080007 | Clear cell renal cell carcinoma metastatic | 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
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 16 | 1 |
| Spain | Authorised, recruiting | 32 | 2 |
| Rest of world
Canada, United States
|
— | 77 | — |
Investigational sites
Institut Gustave Roussy
Innovation Thérapeutique et Essais Précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
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 | 2026-03-25 | 2026-05-06 | |||
| Spain | 2026-04-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-13 | France | Acceptable 2026-02-04
|
2026-02-09 |