Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
220
Countries
2
Sites
2
Metastatic cancer
Key facts
- Sponsor
- Akamis Bio Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 13 Dec 2023
- Decision date (initial)
- 2023-05-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503525-19-00
- ClinicalTrials.gov
- NCT05043714
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Akamis Bio Limited
- Sponsor organisation
- Akamis Bio Limited
- Address
- 4-10 The Quadrant
- City
- Abingdon
- Postcode
- OX14 3YS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Akamis Bio Limited
- Contact name
- Andrew Fox
Public contact point
- Organisation
- Akamis Bio Limited
- Contact name
- Andrew Fox
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 35 | 1 |
| Spain | Ended | 50 | 1 |
| Rest of world
United Kingdom, United States
|
— | 135 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-31 | Belgium | Acceptable 2023-05-23
|
2023-05-23 |