Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
90
Countries
1
Sites
4
Solid tumors
Key facts
- Sponsor
- BeOne Medicines AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Jan 2025 → 9 Jan 2026
- Decision date (initial)
- 2024-12-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514216-27-00
- ClinicalTrials.gov
- NCT06540066
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10025648 | Malignant mast cell tumors unspecified site extranodal and solid organ sites | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BeOne Medicines AG
- Sponsor organisation
- BeOne Medicines AG
- Address
- Aeschengraben 27
- City
- Basel
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 35 | 4 |
| Rest of world
China, United States
|
— | 55 | — |
Investigational sites
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Mirasole S.p.A.
U.O di Oncologia ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Francesco Vito 1, 00168, Rome
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
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 | 2025-01-17 | 2025-01-23 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-23 | Italy | Acceptable 2024-12-09
|
2024-12-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-24 | Italy | Acceptable 2024-12-09
|
2025-02-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-28 | Italy | Acceptable 2025-04-03
|
2025-04-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-17 | Italy | Acceptable 2025-04-03
|
2025-04-17 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-12 | Italy | Acceptable 2025-04-03
|
2025-06-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-02 | Italy | Acceptable 2025-08-05
|
2025-08-06 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-23 | Italy | Acceptable 2025-11-03
|
2025-11-11 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-25 | Italy | Acceptable 2025-11-03
|
2025-11-25 |