Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
161
Countries
1
Sites
2
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
- 18 Mar 2022 → ongoing
- Decision date (initial)
- 2024-08-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515848-23-00
- EudraCT number
- 2019-002203-18
- ClinicalTrials.gov
- NCT04170153
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
- Global Regulatory Affairs
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 27 | 2 |
| Rest of world
Japan, China, United Kingdom, United States
|
— | 134 | — |
Investigational sites
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 | 2022-03-18 | 2022-05-16 | 2022-06-19 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Spain | Acceptable with conditions 2024-08-06
|
2024-08-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-21 | Spain | Acceptable 2025-04-30
|
2025-04-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-13 | Spain | Acceptable 2025-04-30
|
2026-01-13 |