Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
1,149
Countries
2
Sites
11
Platinum-resistant recurrent (PRR) ovarian cancer, Platinum-sensitive recurrent (PSR) ovarian cancer, Lung Adenocarcinoma, and endometrial cancer.
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
- 17 Apr 2024 → ongoing
- Decision date (initial)
- 2024-12-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502576-23-00
- ClinicalTrials.gov
- NCT05797168
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Platinum-resistant recurrent (PRR) ovarian cancer, Platinum-sensitive recurrent (PSR) ovarian cancer, Lung Adenocarcinoma, and endometrial cancer.
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
2 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 17 | 7 |
| Spain | Ongoing, recruiting | 53 | 4 |
| Rest of world
Israel, Korea, Republic of, Turkey, Taiwan, Japan, United Kingdom, United States, Canada, Australia, China
|
— | 1,079 | — |
Investigational sites
Universitaet Leipzig
Klinik und Poliklinik für Frauenheilkunde, Liebigstrasse 20a, Zentrum-Suedost, Leipzig
Medical Center - University Of Freiburg
Klinik für Innere Medizin I Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
KEM I Evang. Kliniken Essen-Mitte gGmbH
Gynaekologie & Gynaekologische Onkologie, Henricistrasse 92, Huttrop, Essen
Medizinische Hochschule Hannover
Klinik für Frauenheilkunde und Geburtshilfe, Feodor-Lynen-Strasse 15, Gross Buchholz, Hanover
Universitaetsklinikum Mannheim GmbH
Abteilung fuer Gynaekologische Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Charite Universitaetsmedizin Berlin KöR
Klinik fuer Gynaekologie mit Zentrum fuer onkologische Chirurgie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Regensburg AöR
Innere Medizin III Haematologie und Internistische Onkologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Hospital Universitari Vall D Hebron
Medical Oncology Department VHIO, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Hm Sanchinarro
START Madrid-HM CIOCC Early Phase Program, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
Servicio de Oncología Médica, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Virgen De La Victoria
IBIMA, Calle Del Arroyo Teatinos Sn, 29010, Malaga
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 | 2025-10-07 | 2025-10-08 | |||
| Spain | 2024-04-17 | 2024-05-08 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-29 | Spain | Acceptable with conditions 2024-01-22
|
2024-01-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-27 | Spain | Acceptable 2024-07-03
|
2024-07-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-29 | Spain | Acceptable 2024-09-13
|
2024-09-13 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-10-16 | Acceptable 2024-09-13
|
2024-12-17 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-23 | Spain | Acceptable 2025-08-29
|
2025-09-01 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-05 | Spain | Acceptable 2026-02-26
|
2026-02-27 |