Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
83
Countries
1
Sites
2
advanced/metastatic solid tumors
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Mar 2023 → 18 Sep 2025
- Decision date (initial)
- 2023-06-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504855-28-00
- EudraCT number
- 2021-005882-42
- WHO UTN
- U1111-1290-2697
- ClinicalTrials.gov
- NCT05514444
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
advanced/metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10025648 | Malignant mast cell tumors unspecified site extranodal and solid organ sites | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Konstantin Dobrenkov
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Konstantin Dobrenkov
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 30 | 2 |
| Rest of world
United States, Israel, Canada
|
— | 53 | — |
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-03-21 | 2025-04-10 | 2023-04-28 | 2024-07-09 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-23 | Netherlands | Acceptable 2023-06-21
|
2023-06-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-10 | Netherlands | Acceptable 2023-09-12
|
2023-09-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-07 | Netherlands | Acceptable 2024-01-17
|
2024-01-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-20 | Netherlands | Acceptable 2025-02-17
|
2025-02-20 |