Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
256
Countries
2
Sites
6
Metastatic Castration-Resistant Prostate Cancer
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Aug 2025 → ongoing
- Decision date (initial)
- 2025-05-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516772-15-00
- ClinicalTrials.gov
- NCT06318273
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
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 44 | 3 |
| Spain | Ongoing, recruiting | 18 | 3 |
| Rest of world
Australia, Canada, United States, Japan, Israel
|
— | 194 | — |
Investigational sites
Centre Oscar Lambret
Département d’Oncologie Médicale, 3 Rue Frederic Combemale, 59000, Lille
Institut Gustave Roussy
Département d’Innovation Thérapeutique et d’Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Department of Medical Oncology, 28 Rue Laennec, 69008, Lyon
Hospital Universitario Hm Sanchinarro
Medical Oncology Service, Calle Ona 10, 28050, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology Service, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari Vall D Hebron
Medical Oncology Department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2025-09-10 | 2025-09-17 | |||
| Spain | 2025-08-29 | 2025-09-03 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-30 | Spain | Acceptable with conditions 2025-05-23
|
2025-05-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-24 | Acceptable with conditions | 2025-07-11 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-16 | Spain | Acceptable with conditions | 2025-08-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-15 | Spain | Acceptable 2025-10-07
|
2025-10-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-03 | Spain | Acceptable 2026-03-16
|
2026-03-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-06-04 | Acceptable | 2026-06-24 |