Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
280
Countries
2
Sites
8
Metastatic or locally advanced 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
- 10 Dec 2022 → 22 Aug 2025
- Decision date (initial)
- 2023-11-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507432-20-00
- EudraCT number
- 2020-000639-28
- ClinicalTrials.gov
- NCT04417465
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic or locally advanced tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced 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
- Calico Life Sciences LLC
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- Calico Life Sciences LLC
- Contact name
- Global Clinical Trials Helpdesk
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 75 | 4 |
| Spain | Ended | 75 | 4 |
| Rest of world
Israel, Japan, Taiwan, Korea, Republic of, United States
|
— | 130 | — |
Investigational sites
Institut De Cancerologie De L Ouest
N/A, Bd Du Professeur Jacques Monod, 44800, St Herblain
Assistance Publique Hopitaux De Paris
N/A, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
CHU De Bordeauxt
N/A, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital Universitario Virgen De La Victoria
N/A, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Fundacion Jimenez Diaz
N/A, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
N/A, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
N/A, Bloque D, Avenida De Cordoba Sn, Madrid
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 | 2022-12-10 | 2025-06-05 | 2023-01-05 | 2024-09-04 | |
| Spain | 2023-05-24 | 2025-08-21 | 2023-06-14 | 2024-09-04 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-31 | France | Acceptable 2023-10-18
|
2023-10-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-25 | France | Acceptable 2024-06-17
|
2024-06-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-23 | France | Acceptable 2024-11-22
|
2024-11-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-04 | France | Acceptable 2025-03-21
|
2025-03-21 |