Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
10
Countries
1
Sites
1
Recurrent glioblastoma
Key facts
- Sponsor
- Oncopeptides AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-05-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Recurrent glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oncopeptides AB
- Sponsor organisation
- Oncopeptides AB
- Address
- 7th Floor, Luntmakargatan 46, Adolf Fredrik Luntmakargatan 46 Adolf Fredrik
- City
- Stockholm
- Postcode
- 111 37
- Country
- Sweden
Scientific contact point
- Organisation
- Oncopeptides AB
- Contact name
- Stefan Norin
Public contact point
- Organisation
- Oncopeptides AB
- Contact name
- Eva Nordström
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-13 | Norway | Acceptable 2026-05-15
|
2026-05-15 |