Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
106
Countries
1
Sites
5
Metastatic or Locally Advanced Unresectable 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
- 21 Sep 2022 → 5 Feb 2026
- Decision date (initial)
- 2022-09-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic or Locally Advanced Unresectable 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
- Communication Center Merck KGaA
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Communication Center Merck KGaA
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 33 | 5 |
| Rest of world
United Kingdom, Korea, Republic of, Australia, Canada, United States
|
— | 73 | — |
Investigational sites
Hospital Universitario Fundacion Jimenez Diaz
Phase I Clinical Trials Unit, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
University Hospital Quirón Madrid
Unidad de Ensayos Clínicos Fases I, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Hm Sanchinarro
START-Madrid-CIOCC, Calle Ona 10, 28050, Madrid
Hospital Quironsalud Barcelona
Oncology - Phase I Unit, Placa D'alfonso Comin 5-7, 08023, 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 |
|---|---|---|---|---|---|
| Spain | 2022-09-21 | 2022-10-03 | 2025-09-09 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-05-18 | Spain | Acceptable 2022-08-29
|
2022-09-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-01-12 | Spain | Acceptable 2023-02-23
|
2023-04-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-15 | Spain | Acceptable 2024-04-19
|
2024-04-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-14 | Spain | Acceptable 2024-07-24
|
2024-08-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-23 | Spain | Acceptable 2024-10-10
|
2024-10-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-29 | Spain | Acceptable | 2024-12-13 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-07 | Spain | Acceptable | 2025-02-07 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-28 | Spain | Acceptable | 2025-02-28 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-05-05 | Spain | Acceptable with conditions 2025-07-28
|
2025-07-31 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-09 | Spain | Acceptable 2026-01-13
|
2026-01-15 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-23 | Spain | Acceptable 2026-01-13
|
2026-01-23 |