Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
43
Countries
2
Sites
3
Solid tumors (including Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), squamous cell carcinoma of the head and neck (HNSCC), and Gastric Cancer (GC))
Key facts
- Sponsor
- One-carbon Therapeutics AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Aug 2025 → ongoing
- Decision date (initial)
- 2025-04-11
- 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
Solid tumors (including Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), squamous cell carcinoma of the head and neck (HNSCC), and Gastric Cancer (GC))
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
One-carbon Therapeutics AB
- Sponsor organisation
- One-carbon Therapeutics AB
- Address
- Fogdevreten 2
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- One-carbon Therapeutics AB
- Contact name
- Ana Slipicevic
Public contact point
- Organisation
- One-carbon Therapeutics AB
- Contact name
- Ana Slipicevic
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 17 | 1 |
| Spain | Ongoing, recruiting | 16 | 2 |
| Rest of world
United Kingdom
|
— | 10 | — |
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 |
|---|---|---|---|---|---|
| France | 2025-09-01 | ||||
| Spain | 2025-08-18 | 2025-08-22 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-16 | Spain | Acceptable with conditions 2025-04-11
|
2025-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-26 | Spain | Acceptable 2025-07-21
|
2025-07-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-04 | Acceptable | 2025-12-09 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-14 | Spain | Acceptable | 2026-05-14 |