Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
45
Countries
2
Sites
3
advanced solid malignancies
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Jun 2025 → 1 May 2026
- Decision date (initial)
- 2025-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
advanced solid malignancies
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 9 | 1 |
| Romania | Ended | 24 | 2 |
| Rest of world
Moldova, Republic of
|
— | 12 | — |
Investigational sites
Multispecialty hospital for active treatment Sveta Sofia EOOD
0901: Department of Medical Oncology, Bulevard Bilgariya 104, 1404, Sofiya
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
6102: Radiotherapy, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
6101: Oncology, Soseaua Fundeni 252, 022328, Bucharest
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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-06-13 | 2026-02-26 | 2025-08-22 | 2025-12-10 | |
| Romania | 2025-06-11 | 2026-04-30 | 2025-06-13 | 2026-01-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-05 | Bulgaria | Acceptable 2025-05-21
|
2025-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-30 | Bulgaria | Acceptable 2025-09-16
|
2025-09-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-03 | Bulgaria | Acceptable 2026-05-07
|
2026-05-11 |