Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
584
Countries
5
Sites
13
Solid tumor cancer and lung cancer
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
- 16 Dec 2021 → ongoing
- Decision date (initial)
- 2024-06-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501563-40-00
- EudraCT number
- 2021-004024-15
- WHO UTN
- U1111-1281-2482
- ClinicalTrials.gov
- NCT05067283
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid tumor cancer and lung cancer
| 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
- Sofia Choi
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Sofia Choi
Locations
5 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 16 | 1 |
| Italy | Ongoing, recruiting | 32 | 3 |
| Lithuania | Ongoing, recruiting | 4 | 2 |
| Poland | Ongoing, recruiting | 60 | 4 |
| Spain | Ongoing, recruiting | 55 | 3 |
| Rest of world
Australia, Malaysia, Korea, Republic of, Chile, United States, Japan, Switzerland, Ukraine, Israel, Panama, Canada, Turkey, China
|
— | 417 | — |
Investigational sites
Azienda Ospedaliera Universitaria Senese
U.O.C. Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Melanoma, Immunoterapia Oncologica, Via Mariano Semmola 52, 80131, Naples
Humanitas Research Hospital
U.O di Oncologia ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Onkologijos ligonine, Volungiu G. 16, Onkologijos ligonine, Kaunas
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Chemoterapijos skyrius su dienos stacionaru, Santariskiu G. 1, Vilniaus M. Sav., Vilnius
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wawelska 15, 02-034, Warsaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Klinika Onkologii Klinicznej i Doświadczalnej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Uniwersyteckie Centrum Kliniczne
Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej., Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Clinica Universidad De Navarra
Oncology Service, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Oncology Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncology Service, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 |
|---|---|---|---|---|---|
| Denmark | 2024-05-30 | 2024-07-19 | |||
| Italy | 2024-06-17 | 2024-07-11 | |||
| Lithuania | 2025-05-12 | 2025-11-11 | |||
| Poland | 2021-12-16 | 2021-12-17 | |||
| Spain | 2022-03-08 | 2022-06-13 |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-16 | Spain | Acceptable 2023-09-07
|
2023-09-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-25 | Spain | Acceptable 2023-11-23
|
2023-11-24 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-12-20 | Acceptable 2023-11-23
|
2024-03-25 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2023-12-20 | Acceptable 2023-11-23
|
2024-04-02 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2023-12-21 | Acceptable 2023-11-23
|
2024-03-13 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-02 | Acceptable 2023-11-23
|
2024-04-02 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-24 | Spain | Acceptable 2024-06-17
|
2024-06-18 |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-02 | Spain | Acceptable with conditions 2024-09-19
|
2024-09-19 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-10-08 | Acceptable with conditions 2024-09-19
|
2025-01-17 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-17 | Acceptable with conditions 2024-09-19
|
2025-01-17 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-14 | Spain | Acceptable 2025-05-23
|
2025-05-23 |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-20 | Spain | Acceptable 2025-09-01
|
2025-09-01 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-08 | Spain | Acceptable 2025-09-01
|
2025-09-08 |
| 14 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-29 | Acceptable | 2025-11-10 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-20 | Spain | Acceptable 2026-04-06
|
2026-04-07 |