Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
6
Countries
1
Sites
2
Non-Small Cell Lung Cancer, cutaneous melanoma, urothelial cancer, renal cell cancer, Squamous Cell Carcinoma of the Head and Neck
Key facts
- Sponsor
- Nec Oncoimmunity AS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 May 2022 → 18 Aug 2025
- Decision date (initial)
- 2024-07-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513716-95-00
- EudraCT number
- 2021-000607-20
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Small Cell Lung Cancer, cutaneous melanoma, urothelial cancer, renal cell cancer, Squamous Cell Carcinoma of the Head and Neck
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nec Oncoimmunity AS
- Sponsor organisation
- Nec Oncoimmunity AS
- Address
- Ullernchausseen 64
- City
- Oslo
- Postcode
- 0379
- Country
- Norway
Scientific contact point
- Organisation
- Nec Oncoimmunity AS
- Contact name
- Project Leader
Public contact point
- Organisation
- Nec Oncoimmunity AS
- Contact name
- Project Leader
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Lithuania | Ended | 6 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Lithuania | 2022-05-16 | 2025-08-18 | 2022-05-16 | 2025-04-02 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-09 | Lithuania | Acceptable 2024-06-11
|
2024-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-04 | Lithuania | Acceptable 2024-12-09
|
2024-12-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-02 | Lithuania | Acceptable 2025-05-12
|
2025-06-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-23 | Lithuania | Acceptable 2025-05-12
|
2025-07-23 |