Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
85
Countries
1
Sites
4
Advanced Solid Tumors
Key facts
- Sponsor
- BeOne Medicines I GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 May 2026 → ongoing
- Decision date (initial)
- 2026-04-30
- 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
Advanced Solid Tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BeOne Medicines I GmbH
- Sponsor organisation
- BeOne Medicines I GmbH
- Address
- Aeschengraben 27
- City
- Basel
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- BeOne Medicines I GmbH
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- BeOne Medicines I GmbH
- Contact name
- BeOne Medical Officer
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 24 | 4 |
| Rest of world
China, United States, Australia
|
— | 61 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 |
|---|---|---|---|---|---|
| Spain | 2026-05-19 | 2026-05-19 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-20 | Spain | Acceptable 2026-04-29
|
2026-04-30 |