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 | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
| 28.0 | PT | 10089216 | PD-L1 protein expression | 100000004848 |
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
| 21.0 | LLT | 10033600 | Pancreatic adenocarcinoma non-resectable | 10029104 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
| 21.1 | LLT | 10025734 | Malignant neoplasm of biliary tract part unspecified | 10029104 |
| 27.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
| 24.0 | LLT | 10085300 | Squamous non-small cell lung cancer | 100000004848 |
| 27.0 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 27.0 | PT | 10063157 | Metastatic glioma | 100000004864 |
| 20.0 | PT | 10018338 | Glioma | 100000004864 |
| 20.0 | LLT | 10028982 | Neoplasm biliary tract | 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
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
Australia, United States, Korea, Republic of, 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 Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 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 |
|---|---|---|---|---|---|
| Denmark | 2025-08-06 | 2025-08-06 | |||
| France | 2025-07-09 | 2025-07-09 | |||
| Spain | 2025-03-24 | 2025-03-24 |
Application history
9 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 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-04-30 | Acceptable 2026-06-08
|
2026-06-16 |