Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
2
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
- 23 Feb 2024 → 14 Apr 2026
- Decision date (initial)
- 2024-02-01
- 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
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
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 · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 12 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Central Hospital Of Northern Pest Military Hospital
Oncology, Podmaniczky Utca 109, 1062, Budapest VI
Pharmaceutical Research Associates Magyarorszag
N/A, Rottenbiller Utca 13, 1077, Budapest
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 |
|---|---|---|---|---|---|
| Hungary | 2024-02-23 | 2026-04-14 | 2024-03-25 | 2025-09-15 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-06 | Hungary | Acceptable 2024-01-30
|
2024-02-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-10 | Hungary | Acceptable 2024-05-21
|
2024-05-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-13 | Hungary | Acceptable 2024-11-21
|
2024-11-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-29 | Hungary | Acceptable 2024-11-21
|
2025-01-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-01 | Hungary | Acceptable | 2025-05-13 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-18 | Hungary | Acceptable 2025-07-25
|
2025-07-29 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-29 | Hungary | Acceptable 2025-07-25
|
2026-01-29 |