Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
4
Advanced Solid Tumors
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
- 26 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521614-26-00
- ClinicalTrials.gov
- NCT07161414
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
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
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 13 | 4 |
| Rest of world
United States, United Kingdom, Korea, Republic of
|
— | 27 | — |
Investigational sites
Clinica Universidad De Navarra
7001: Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Clinic De Barcelona
7004: Oncología Médica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
7002: Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
7003: Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, 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 |
|---|---|---|---|---|---|
| Spain | 2026-02-26 | 2026-04-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-12 | Spain | Acceptable 2026-01-14
|
2026-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-19 | Spain | Acceptable 2026-03-26
|
2026-03-30 |