Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
27
Countries
2
Sites
5
Advanced Solid Tumors Who Are Beyond Standard of Care
Key facts
- Sponsor
- Abalos Therapeutics GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-04-28
- 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
Advanced Solid Tumors Who Are Beyond Standard of Care
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abalos Therapeutics GmbH
- Sponsor organisation
- Abalos Therapeutics GmbH
- Address
- Merowingerplatz 1 A, Bilk Bilk
- City
- Duesseldorf
- Postcode
- 40225
- Country
- Germany
Scientific contact point
- Organisation
- Abalos Therapeutics GmbH
- Contact name
- Senior Director Clinical Operations
Public contact point
- Organisation
- Abalos Therapeutics GmbH
- Contact name
- Senior Director Clinical Operations
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Not authorised | 12 | 2 |
| Spain | Not authorised | 15 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-13 | Germany | Not acceptable 2025-04-22
|
2025-04-28 |