Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
580
Countries
3
Sites
10
Advanced, or metastatic solid tumors with methylthioadenosine phosphorylase (MTAP) homozygous deletion and/or lost MTAP protein expression
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
- 24 Mar 2025 → ongoing
- Decision date (initial)
- 2025-07-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515307-19-00
- ClinicalTrials.gov
- NCT06589596
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced, or metastatic solid tumors with methylthioadenosine phosphorylase (MTAP) homozygous deletion and/or lost MTAP protein expression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10028982 | Neoplasm biliary tract | 10029104 |
| 20.0 | PT | 10018338 | Glioma | 100000004864 |
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
| 21.1 | LLT | 10025734 | Malignant neoplasm of biliary tract part unspecified | 10029104 |
| 21.0 | LLT | 10033600 | Pancreatic adenocarcinoma non-resectable | 10029104 |
| 24.0 | LLT | 10085300 | Squamous non-small cell lung cancer | 100000004848 |
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
| 28.0 | PT | 10089216 | PD-L1 protein expression | 100000004848 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 27.0 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 27.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
| 27.0 | PT | 10063157 | Metastatic glioma | 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
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 9 | 1 |
| France | Ongoing, recruiting | 40 | 5 |
| Spain | Ongoing, recruiting | 30 | 4 |
| Rest of world
Korea, Republic of, Australia, United States, China
|
— | 501 | — |
Investigational sites
Rigshospitalet
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Bergonie
Medical oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Curie
Department of Drug Development and Innovation (D3i), 26 Rue D Ulm, 75005, Paris
Institut Gustave Roussy
Department of Drug Development, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Paoli Calmettes
oncology department, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 |
|---|---|---|---|---|---|
| Denmark | 2025-08-06 | 2025-08-06 | |||
| France | 2025-07-09 | 2025-07-09 | |||
| Spain | 2025-03-24 | 2025-03-24 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-25 | France | Acceptable 2025-01-24
|
2025-01-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-18 | France | Acceptable | 2025-04-16 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-03-14 | 2025-05-22 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-17 | France | Acceptable | 2025-05-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-30 | France | Acceptable 2025-07-15
|
2025-07-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-04 | France | Acceptable 2025-09-26
|
2025-09-26 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-15 | France | Acceptable 2026-03-25
|
2026-03-31 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-20 | France | Acceptable 2026-03-25
|
2026-04-20 |