Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
5
Adult patients with advanced solid tumors
Key facts
- Sponsor
- Invios GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 22 Aug 2023 → 20 Nov 2024
- Decision date (initial)
- 2023-07-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adult patients with advanced solid tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Invios GmbH
- Sponsor organisation
- Invios GmbH
- Address
- Campus-Vienna-Biocenter 5, Landstrasse Landstrasse
- City
- Vienna
- Postcode
- 1030
- Country
- Austria
Scientific contact point
- Organisation
- Invios GmbH
- Contact name
- Romana Gugenberger
Public contact point
- Organisation
- Invios GmbH
- Contact name
- Romana Gugenberger
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 12 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Department of Internal Medicine V, Hematology and Oncology, Anichstrasse 35, 6020, Innsbruck
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Department for Transfusion Medicine and Cell Therapy, Waehringer Guertel 18-20, Alsergrund, Vienna
SCRI CCCIT Ges.m.b.H.
III. Med. Department of Hematology,Medical Oncology,Hemostaseology,Infectious Disease&Rheumatology, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Barmherzige Schwestern, Department of HNO/Head & Neck Surgery, Seilerstaette 4, 4020, Linz
Ordensklinikum Linz GmbH
Elisabethinen, Department of Hematology & Oncology, Fadingerstrasse 1, 4020, Linz
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 |
|---|---|---|---|---|---|
| Austria | 2023-08-22 | 2024-11-20 | 2023-08-22 | 2024-04-03 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-31 | Austria | Acceptable with conditions 2023-07-17
|
2023-07-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-05 | Austria | Acceptable 2024-04-02
|
2024-04-08 |