Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
112
Countries
2
Sites
6
Malignant Neoplasm - 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
- 11 Mar 2025 → ongoing
- Decision date (initial)
- 2025-03-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516006-32-00
- WHO UTN
- U1111-1310-1179
- ClinicalTrials.gov
- NCT05853367
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Malignant Neoplasm - Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
| 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, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Andrew Chow
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Andrew Chow
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 8 | 2 |
| Spain | Ongoing, recruiting | 22 | 4 |
| Rest of world
Israel, United States, Switzerland, Chile, Canada
|
— | 82 | — |
Investigational sites
Uniwersyteckie Centrum Kliniczne
Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Poland | 2025-03-24 | 2025-03-27 | |||
| Spain | 2025-03-11 | 2025-03-19 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | Spain | Acceptable 2025-02-24
|
2025-02-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-10 | Spain | Acceptable 2025-05-26
|
2025-05-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-03 | Spain | Acceptable | 2025-06-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-14 | Spain | Acceptable 2025-08-22
|
2025-08-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-03 | Spain | Acceptable 2025-11-04
|
2025-11-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-14 | Spain | Acceptable 2026-03-02
|
2026-03-07 |