Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Under evaluation
Participants planned
149
Countries
1
Sites
3
advanced refractory solid tumors
Key facts
- Sponsor
- Samsung Bioepis Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-05-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
advanced refractory solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Samsung Bioepis Co. Ltd.
- Sponsor organisation
- Samsung Bioepis Co. Ltd.
- Address
- 76 Songdogyoyuk Ro
- City
- Yeonsu
- Postcode
- 21987
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Samsung Bioepis Co. Ltd.
- Contact name
- Regulatory affairs
Public contact point
- Organisation
- Samsung Bioepis Co. Ltd.
- Contact name
- Regulatory affairs
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 40 | 3 |
| Rest of world
Korea, Republic of, Australia, United States
|
— | 109 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-19 | Spain | Acceptable with conditions 2026-05-11
|
2026-05-18 |