Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
16
Countries
1
Sites
5
colorectal cancer
Key facts
- Sponsor
- NEOGAP Therapeutics AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Apr 2023 → ongoing
- Decision date (initial)
- 2024-09-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512296-13-00
- EudraCT number
- 2022-000394-96
- ClinicalTrials.gov
- NCT05908643
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
NEOGAP Therapeutics AB
- Sponsor organisation
- NEOGAP Therapeutics AB
- Address
- Visionsgatan 56
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- NEOGAP Therapeutics AB
- Contact name
- Chief Technical Officer
Public contact point
- Organisation
- NEOGAP Therapeutics AB
- Contact name
- Chief Executive Officer
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 16 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Danderyds Sjukhus AB
Department of Surgery and Urology, Morbygardsvagen 88, 182 88, Danderyd
Karolinska University Hospital
Medical Unit Pelvic cancer - Colorectal cancer, Theme Cancer, Eugeniavagen 3, 171 64, Solna
Karolinska University Hospital
Medical Unit Cell therapy and Allogeneic stem cell transplantation (ME CAST), Halsovagen, Flemingsberg, Huddinge
Västmanlands sjukhus Västerås
Department of Surgery, Sigtunagatan, Sweden
Karolinska University Hospital
Phase 1 unit, Center for Clinical Cancer Studies, Theme Cancer, Eugeniavagen 3, 171 64, Solna
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 |
|---|---|---|---|---|---|
| Sweden | 2023-04-03 | 2023-04-05 | 2026-05-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-22 | Sweden | Acceptable with conditions 2024-09-05
|
2024-09-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-11 | Sweden | Acceptable 2025-05-20
|
2025-05-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-24 | Sweden | Acceptable | 2025-07-17 |