Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
18
Countries
1
Sites
5
resectable esophagogastric adenocarcinoma
Key facts
- Sponsor
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Dec 2025 → ongoing
- Decision date (initial)
- 2025-08-27
- 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
resectable esophagogastric adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10056267 | Gastroesophageal cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Sponsor organisation
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Address
- Steinbacher Hohl 2-26, Praunheim Praunheim
- City
- Frankfurt Am Main
- Postcode
- 60488
- Country
- Germany
Scientific contact point
- Organisation
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Contact name
- Clinical Trial Project Manager
Public contact point
- Organisation
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Contact name
- Clinical Trial Project Manager
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 18 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Krankenhaus Nordwest GmbH
Institut für Klinisch-Onkologische Forschung (IKF), Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Universitaet Leipzig
Medizinische Klinik 2 (Onkologie, Gastroenterologie, Hepatologie, Pneumologie), Liebigstrasse 22, Zentrum-Suedost, Leipzig
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
Norddeutsches Studienzentrum für Innovative Onkologie, Orchideenstieg 12-14, 22297, Hamburg
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Med. Klinik und Poliklinik III Hämatologie und Onkologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Asklepios Kliniken Hamburg GmbH
Asklepios Tumorzentrum Hamburg, Klinik Altona, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
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 | 2025-12-12 | 2026-01-28 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-30 | Germany | Acceptable 2025-08-26
|
2025-08-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-01 | Germany | Acceptable 2025-10-28
|
2025-11-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-12 | Germany | Acceptable 2025-12-08
|
2025-12-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-10 | Germany | Acceptable 2025-12-08
|
2025-12-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-15 | Germany | Acceptable | 2026-01-30 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-20 | Germany | Acceptable 2026-05-18
|
2026-05-21 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-21 | Germany | 2026-05-21 |