Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
285
Countries
2
Sites
9
Selected Advanced or Metastatic 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
- 28 Apr 2026 → ongoing
- Decision date (initial)
- 2026-04-15
- 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
Selected Advanced or Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
| 27.0 | LLT | 10077738 | Hepatocellular carcinoma metastatic | 10029104 |
| 21.0 | LLT | 10019829 | Hepatocellular carcinoma recurrent | 10029104 |
| 24.0 | LLT | 10085300 | Squamous non-small cell lung cancer | 100000004848 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
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
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 39 | 5 |
| Italy | Authorised, recruiting | 17 | 4 |
| Rest of world
United States, Korea, Republic of, New Zealand, China, Japan
|
— | 229 | — |
Investigational sites
Hopital Beaujon
Unité Cancer du foie et innovation thérapeutique, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Nantes
Oncologie Medicale, 1 Place Alexis Ricordeau, 44000, Nantes
Institut Gustave Roussy
Département d'innovation Thérapeutique et des Essais Précoces (DITEP), 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Institut Regional Du Cancer De Montpellier
Oncologie Medicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centr Georges Francois Leclerc
Oncologie Medicale, 1 Rue Professeur Marion, 21000, Dijon
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Medical Oncology, Largo Francesco Vito 1, 00168, Rome
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Sperimentazioni cliniche, Via Mariano Semmola 52, 80131, Naples
Istituto Oncologico Veneto
Medical Oncology 1 Unit, Via Gattamelata 64, 35128, Padova
Humanitas Mirasole S.p.A.
Operating Unit of Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
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 |
|---|---|---|---|---|---|
| France | 2026-04-28 | 2026-05-07 | |||
| Italy | 2026-04-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-05 | Italy | Acceptable 2026-04-14
|
2026-04-15 |