Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
77
Countries
3
Sites
4
CD123-Positive Hematological Malignancies: Module 1 focuses on R/R Acute Myeloid Leukemia and R/R Myelodysplastic Syndrome.
Key facts
- Sponsor
- Astrazeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 9 Oct 2024 → 25 Feb 2026
- Decision date (initial)
- 2024-05-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506997-11-00
- ClinicalTrials.gov
- NCT06179511
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
CD123-Positive Hematological Malignancies: Module 1 focuses on R/R Acute Myeloid Leukemia and R/R Myelodysplastic Syndrome.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- 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
3 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 4 | 1 |
| Italy | Ended | 4 | 1 |
| Spain | Ended | 6 | 2 |
| Rest of world
Japan, Taiwan, United States, Korea, Republic of, United Kingdom, China, Australia
|
— | 63 | — |
Investigational sites
Goethe University Frankfurt
Med. Klinik 2 – Haematologie Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
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 |
|---|---|---|---|---|---|
| Germany | 2024-10-21 | 2025-01-10 | 2025-10-15 | ||
| Italy | 2024-10-11 | 2024-11-06 | 2025-10-15 | ||
| Spain | 2024-10-09 | 2026-02-24 | 2024-11-05 | 2025-10-15 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-12 | Spain | Acceptable 2024-05-06
|
2024-05-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-05 | Spain | Acceptable 2024-09-02
|
2024-09-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-17 | Spain | Acceptable 2025-04-14
|
2025-04-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-18 | Acceptable 2025-04-14
|
2025-07-18 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-20 | Acceptable 2025-04-14
|
2025-11-20 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-21 | Acceptable 2025-04-14
|
2025-11-21 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-26 | Spain | Acceptable 2026-01-08
|
2026-01-13 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-05 | Spain | Acceptable 2026-01-08
|
2026-03-05 |