Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
220
Countries
2
Sites
14
locally advanced or metastatic solid tumors
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Aug 2024 → ongoing
- Decision date (initial)
- 2024-07-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506227-29-00
- ClinicalTrials.gov
- NCT06084481
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
locally advanced or metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10016180 | Fallopian tube cancer | 100000004864 |
| 20.0 | LLT | 10028982 | Neoplasm biliary tract | 10029104 |
| 24.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.1 | LLT | 10049010 | Carcinoma hepatocellular | 10029104 |
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
| 25.1 | PT | 10061534 | Oesophageal squamous cell carcinoma | 100000004864 |
| 21.0 | LLT | 10056065 | Oesophageal squamous cell carcinoma stage unspecified | 10029104 |
| 20.0 | PT | 10061328 | Ovarian epithelial cancer | 100000004864 |
| 24.1 | LLT | 10086155 | Primary peritoneal carcinosarcoma | 100000004848 |
| 21.1 | LLT | 10051971 | Pancreatic adenocarcinoma | 10029104 |
| 26.1 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
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 · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Not authorised | 24 | 6 |
| Spain | Ongoing, recruitment ended | 36 | 8 |
| Rest of world
Israel, United States, Japan, Korea, Republic of, Taiwan, Australia
|
— | 160 | — |
Investigational sites
Centre Leon Berard
401 : Department of Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut De Cancerologie De L Ouest
402 : Medical Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Centr Georges Francois Leclerc
403 : Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Curie
405 : Department of Drug Development and Innovation, 26 Rue D Ulm, 75005, Paris
Institut Bergonie
404 : Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
400 : DITEP Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital General Universitario Gregorio Maranon
607 : Neumología, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitari Vall D Hebron
606 : Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
602 : Oncología Médica, Calle Ona 10, 28050, Madrid
Hospital Hm Nou Delfos
608 : Oncología, Avinguda De Vallcarca 151, 08023, Barcelona
Clinica Universidad De Navarra
605 : Oncología Medica, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
600 : Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
610 : Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Institut Catala D'oncologia
609 : Oncología Médica, Carretera Canyet S/n, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Spain | 2024-08-30 | 2024-09-26 | 2026-01-07 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-24 | Spain | Acceptable 2024-07-23
|
2024-07-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-11 | Spain | Acceptable 2025-02-19
|
2025-02-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-13 | Spain | Acceptable 2025-08-19
|
2025-08-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-24 | Spain | Acceptable 2026-01-21
|
2026-01-26 |