Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
77
Countries
1
Sites
4
Progressive metastatic solid cancer after failure of established treatment options
Key facts
- Sponsor
- Deutsches Krebsforschungszentrum (DKFZ)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 12 Jan 2024 → ongoing
- Decision date (initial)
- 2023-11-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-503084-15-00
- ClinicalTrials.gov
- NCT05999396
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Progressive metastatic solid cancer after failure of established treatment options
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10024193 | Leiomyosarcoma NOS | 10029104 |
| 21.1 | LLT | 10006188 | Breast cancer female NOS | 10029104 |
| 20.0 | LLT | 10024631 | Liposarcoma NOS | 10029104 |
| 21.0 | LLT | 10010029 | Colorectal cancer NOS | 10029104 |
| 20.0 | LLT | 10031295 | Osteosarcoma NOS | 10029104 |
| 20.0 | LLT | 10042866 | Synovial sarcoma NOS | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Deutsches Krebsforschungszentrum (DKFZ)
- Sponsor organisation
- Deutsches Krebsforschungszentrum (DKFZ)
- Address
- Im Neuenheimer Feld 280, Neuenheim Neuenheim
- City
- Heidelberg
- Postcode
- 69120
- Country
- Germany
Scientific contact point
- Organisation
- Deutsches Krebsforschungszentrum (DKFZ)
- Contact name
- KKE Translational Immunology, University Hospital Tuebingen
Public contact point
- Organisation
- Deutsches Krebsforschungszentrum (DKFZ)
- Contact name
- ZKS Tübingen
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 77 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Medical Center - University Of Freiburg
Gastroinestinale Onkologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Charite Universitaetsmedizin Berlin KöR
Klinik für Hämato-Onkologie, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Frankfurt AöR
Medizinische Klinik 1, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Tuebingen AöR
KKE Translationale Immunologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
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 | 2024-01-12 | 2024-02-01 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-14 | Germany | Acceptable 2023-11-17
|
2023-11-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-16 | Germany | Acceptable 2024-06-28
|
2024-07-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-21 | Germany | Acceptable 2025-03-10
|
2025-03-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-11 | Germany | Acceptable 2025-10-02
|
2025-10-06 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-16 | Germany | Acceptable 2026-04-27
|
2026-04-30 |