Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
252
Countries
2
Sites
17
Advanced solid tumors
Key facts
- Sponsor
- Merck Healthcare KGaA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Oct 2022 → ongoing
- Decision date (initial)
- 2024-08-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500508-23-00
- ClinicalTrials.gov
- NCT05464030
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Healthcare KGaA
- Sponsor organisation
- Merck Healthcare KGaA
- Address
- Frankfurter Strasse 250
- City
- Darmstadt
- Postcode
- 64293
- Country
- Germany
Scientific contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Locations
2 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 21 | 5 |
| Spain | Ongoing, recruiting | 95 | 12 |
| Rest of world
Japan, United States, Canada, Korea, Republic of
|
— | 136 | — |
Investigational sites
Universitaetsklinikum Mannheim GmbH
Oncology, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Charite Universitaetsmedizin Berlin KöR
Oncology, Augustenburger Platz 1, Wedding, Berlin
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Oncology, Langenbeckstrasse 1, Oberstadt, Mainz
Technische Universitaet Dresden
Oncology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaet Leipzig
Oncology, Liebigstrasse 22, Zentrum-Suedost, Leipzig
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinic De Barcelona
Oncologia Medica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Quironsalud Madrid
Unidad de Ensayos Clínicos Fases I, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Vall D Hebron Institute Of Research
Oncology - Phase I Unit, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital General Universitario Reina Sofia
Servicio de Oncologia Médica, Avenida Menendez Pidal S/n, 14004, Cordoba
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 | 2022-10-28 | 2022-12-02 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-06-14 | Spain | Acceptable with conditions 2022-09-12
|
2022-09-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-10-04 | Spain | Acceptable 2022-11-14
|
2022-11-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-12 | Spain | Acceptable 2023-07-12
|
2023-07-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-08-31 | Spain | Acceptable 2023-10-13
|
2023-10-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-11-02 | Spain | Acceptable 2024-02-02
|
2024-02-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-03-04 | Spain | Acceptable 2024-04-12
|
2024-04-12 |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-05-24 | 2024-08-02 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-08-23 | Spain | Acceptable 2024-10-01
|
2024-10-14 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-18 | Spain | Acceptable 2024-10-01
|
2024-10-18 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-06 | Spain | Acceptable 2025-01-24
|
2025-01-24 |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-02-28 | Spain | Acceptable 2025-04-14
|
2025-04-14 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-04-30 | Spain | Acceptable | 2025-05-09 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-09 | Spain | Acceptable | 2025-09-09 |