Overview
Sponsor-declared trial summary
Locally advanced and metastatic solid tumor including non-small cell lung carcinoma, renal cell carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer, gastric/GEJ cancer, cervical, anal, or MSI-high tumors
Key facts
- Sponsor
- Nykode Therapeutics ASA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jan 2022 → 10 Oct 2024
- Decision date (initial)
- 2024-04-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509996-18-00
- EudraCT number
- 2020-006025-56
- ClinicalTrials.gov
- NCT05018273
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced and metastatic solid tumor including non-small cell lung carcinoma, renal cell carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer, gastric/GEJ cancer, cervical, anal, or MSI-high tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.0 | PT | 10041823 | Squamous cell carcinoma | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10061424 | Anal cancer | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 21.1 | LLT | 10038407 | Renal cell cancer | 10029104 |
| 21.1 | LLT | 10077840 | Urothelial cancer of renal pelvis | 10029104 |
| 20.1 | PT | 10079618 | Microsatellite instability cancer | 100000004864 |
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nykode Therapeutics ASA
- Sponsor organisation
- Nykode Therapeutics ASA
- Address
- Gaustadalleen 21
- City
- Oslo
- Postcode
- 0349
- Country
- Norway
Scientific contact point
- Organisation
- Nykode Therapeutics ASA
- Contact name
- Mette Vinge
Public contact point
- Organisation
- Nykode Therapeutics ASA
- Contact name
- Mette Vinge
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 20 | 2 |
| Spain | Ended | 20 | 5 |
| Rest of world
United States
|
— | 20 | — |
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 |
|---|---|---|---|---|---|
| Germany | 2022-01-18 | 2024-10-09 | 2022-02-24 | 2024-05-07 | |
| Spain | 2022-01-20 | 2024-09-16 | 2022-03-18 | 2024-05-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-25 | Spain | Acceptable 2024-04-04
|
2024-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-06 | Spain | Acceptable 2024-07-15
|
2024-07-19 |