Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
110
Countries
1
Sites
3
Advanced or 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
- 22 Jun 2022 → ongoing
- Decision date (initial)
- 2023-07-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505067-36-00
- EudraCT number
- 2021-005220-38
- WHO UTN
- U1111-1290-8722
- ClinicalTrials.gov
- NCT05382325
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 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
- Julia Cohen
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Julia Cohen
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 30 | 3 |
| Rest of world
United States, Canada, Israel
|
— | 80 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Clinical Research Unit, Plesmanlaan 121, 1066 CX, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
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 | 2022-06-22 | 2022-07-11 | 2024-08-19 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-20 | Netherlands | Acceptable 2023-07-28
|
2023-07-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-29 | Netherlands | Acceptable 2024-04-17
|
2024-04-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-30 | Netherlands | Acceptable 2024-06-26
|
2024-06-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-18 | Netherlands | Acceptable 2025-01-27
|
2025-01-30 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-24 | Netherlands | Acceptable 2025-01-27
|
2025-02-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-17 | Netherlands | Acceptable 2025-07-01
|
2025-07-02 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-20 | Netherlands | Acceptable 2025-07-01
|
2025-08-20 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-28 | Netherlands | Acceptable 2025-12-09
|
2025-12-10 |