Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
222
Countries
2
Sites
3
Advanced 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
- 15 Jun 2021 → 9 Jun 2025
- Decision date (initial)
- 2023-07-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500821-34-00
- EudraCT number
- 2020-004089-20
- WHO UTN
- U1111-1278-2766
- ClinicalTrials.gov
- NCT03918278
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 | 10065252 | Solid tumor | 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
- Mei Chen
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Mei Chen
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 16 | 2 |
| Spain | Ended | 22 | 1 |
| Rest of world
Australia, Israel, Chile, United States, Canada, Korea, Republic of
|
— | 184 | — |
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 |
|---|---|---|---|---|---|
| Italy | 2021-12-22 | 2025-02-17 | 2021-12-29 | 2023-05-23 | |
| Spain | 2021-06-15 | 2024-09-26 | 2021-07-08 | 2023-05-23 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-12 | Italy | Acceptable 2023-07-19
|
2023-07-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-28 | Italy | Acceptable 2023-11-29
|
2023-11-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-02 | Italy | Acceptable 2024-03-11
|
2024-03-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-15 | Italy | Acceptable 2024-08-19
|
2024-08-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-25 | Italy | Acceptable 2025-01-14
|
2025-01-16 |