Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
471
Countries
1
Sites
8
Advanced or metastatic solid tumors including hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2-) breast cancer
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
- 22 May 2024 → ongoing
- Decision date (initial)
- 2024-02-26
- 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 or metastatic solid tumors including hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2-) breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10024627 | Liposarcoma | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 20.0 | PT | 10025031 | Lung adenocarcinoma | 100000004864 |
| 21.0 | PT | 10061534 | Oesophageal squamous cell carcinoma | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 20.0 | LLT | 10027150 | Melanoma malignant | 10029104 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
| 20.0 | PT | 10015560 | Ewing's sarcoma | 100000004864 |
| 20.0 | PT | 10001388 | Adrenocortical carcinoma | 100000004864 |
| 28.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
| 23.0 | PT | 10065430 | HER2 positive breast cancer | 100000004864 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 20.0 | PT | 10060862 | Prostate 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
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 91 | 8 |
| Rest of world
Brazil, China, United States, Thailand, New Zealand, Moldova, Republic of, Malaysia, Korea, Republic of, Australia
|
— | 380 | — |
Investigational sites
Centre De Lutte Contre Le Cancer Eugene Marquis
Medical oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Oscar Lambret
Medical Oncology, 3 Rue Frederic Combemale, 59000, Lille
Centre Francois Baclesse
Medical Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Curie
Medical Oncology, 26 Rue D Ulm, 75005, Paris
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
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 | 2024-05-22 | 2024-05-31 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-01 | France | Acceptable 2024-02-19
|
2024-02-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-12 | France | Acceptable with conditions 2024-06-03
|
2024-06-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-15 | France | Acceptable 2024-09-30
|
2024-09-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-15 | France | Acceptable 2024-12-02
|
2024-12-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-16 | France | Acceptable 2025-02-12
|
2025-02-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-06 | France | Acceptable with conditions 2025-08-14
|
2025-08-14 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-10 | France | Acceptable 2025-12-16
|
2025-12-16 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-19 | France | Acceptable 2025-12-16
|
2025-12-19 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-13 | France | Acceptable 2026-04-30
|
2026-06-01 |