Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
80
Countries
1
Sites
5
Metastatic Castration-resistant Prostate Cancer
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513987-24-00
- WHO UTN
- U1111-1307-2450
- ClinicalTrials.gov
- NCT06067841
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Castration-resistant Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10076506 | Castration-resistant prostate 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
- 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 · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 22 | 5 |
| Rest of world
Canada, United States
|
— | 58 | — |
Investigational sites
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Institut Paoli Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Assistance Publique Hopitaux De Paris
Oncology, 20 Rue Leblanc, 75015, Paris
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-05-11 | France | Acceptable 2026-06-26
|
2026-06-26 |