Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
86
Countries
2
Sites
9
Advanced and Metastatic 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
- 15 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-12
- 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 and Metastatic Solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 27.0 | LLT | 10084066 | Triple negative breast cancer metastatic | 100000004871 |
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
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 6 | 4 |
| Spain | Ongoing, recruiting | 9 | 5 |
| Rest of world
Australia, China, United States
|
— | 71 | — |
Investigational sites
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Dipartimento di Ricerca Traslazionale a supporto dei percorsi oncologici, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Fase 1, Largo Francesco Vito 1, 00168, Rome
Humanitas Mirasole S.p.A.
U.O. Oncologia ed Ematologia - Unità di fase I, Via Alessandro Manzoni 56, 20089, Rozzano
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
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 |
|---|---|---|---|---|---|
| Italy | 2026-04-15 | 2026-04-15 | |||
| Spain | 2026-04-15 | 2026-04-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-25 | Italy | Acceptable 2026-03-09
|
2026-03-12 |