Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
354
Countries
3
Sites
14
Advanced solid tumors
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Feb 2024 → ongoing
- Decision date (initial)
- 2023-12-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505594-32-00
- ClinicalTrials.gov
- NCT05537740
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
3 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 44 | 4 |
| France | Ongoing, recruitment ended | 26 | 4 |
| Spain | Ongoing, recruitment ended | 33 | 6 |
| Rest of world
United Kingdom, China, Singapore, United States, Canada
|
— | 251 | — |
Investigational sites
UZ Leuven
General Medical Oncology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Medical Oncology - Phase I unit, Corneel Heymanslaan 10, 9000, Gent
Centre hospitalier universitaire de Liege
Medical Oncology Department, Avenue De L'hopital 1, 4000, Liege
Antwerp University Hospital
Medical Oncology - Phase I unit, Drie Eikenstraat 655, 2650, Edegem
Centre Oscar Lambret
Departement d'Oncologie Medicale, 3 Rue Frederic Combemale, 59000, Lille
Institut Bergonie
Departement d'Oncologie, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
Drug development Department - DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Departement d'Oncologie, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Fundacion Rioja Salud
Early Phase Clinical Trials, Calle Piqueras 98, 26006, Logrono
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncology, 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 |
|---|---|---|---|---|---|
| Belgium | 2024-02-20 | 2024-02-28 | 2025-09-08 | ||
| France | 2025-01-15 | 2025-02-07 | 2025-09-08 | ||
| Spain | 2024-09-17 | 2024-09-30 | 2025-09-08 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-25 | Belgium | Acceptable with conditions 2023-12-11
|
2023-12-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-06 | Belgium | Acceptable with conditions | 2024-02-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-12 | Belgium | Acceptable with conditions 2024-05-23
|
2024-05-23 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-06-04 | Acceptable with conditions 2024-05-23
|
2024-08-29 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-06-04 | Acceptable with conditions 2024-05-23
|
2024-07-08 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-23 | Belgium | Acceptable 2025-01-15
|
2025-01-15 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-27 | Acceptable 2025-01-15
|
2025-01-27 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-06 | Belgium | Acceptable 2025-05-13
|
2025-05-13 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-30 | Acceptable | 2025-07-22 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-01 | Belgium | Acceptable | 2025-07-31 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-26 | Belgium | Acceptable 2025-11-17
|
2025-11-18 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-15 | Belgium | Acceptable 2025-11-17
|
2026-04-15 |