Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
84
Countries
1
Sites
4
Patients suffering from cancer without further treatment options.
Key facts
- Sponsor
- Adamed Pharma S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Jul 2025 → ongoing
- Decision date (initial)
- 2025-01-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients suffering from cancer without further treatment options.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Adamed Pharma S.A.
- Sponsor organisation
- Adamed Pharma S.A.
- Address
- Ul. Mariana Adamkiewicza 6a, Pienkow Pienkow
- City
- Czosnow
- Postcode
- 05-152
- Country
- Poland
Scientific contact point
- Organisation
- Adamed Pharma S.A.
- Contact name
- Blanka Seklecka
Public contact point
- Organisation
- Adamed Pharma S.A.
- Contact name
- Blanka Seklecka
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 84 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Gdański Uniwersytet Medyczny, Ul. Debinki 7, 80-211, Gdansk
Umed Clinical Trials Sp. z o.o.
Klinika Onkologii Klinicznej, Bud A-2, Ul. Pomorska 251, Lodz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków / Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Onkologii Klinicznej, Ul. Mikolaja Kopernika 50, 31-501, Cracow
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 | 2025-07-09 | 2025-08-05 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-08 | Poland | Acceptable with conditions 2025-01-21
|
2025-01-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-28 | Poland | Acceptable 2025-05-19
|
2025-05-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-11 | Poland | Acceptable 2025-10-30
|
2025-11-03 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-06-02 | Poland | Acceptable 2025-10-30
|
2026-06-02 |