Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
263
Countries
1
Sites
3
Advanced or metastatic solid tumors
Key facts
- Sponsor
- Beigene Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Jan 2024 → 9 Feb 2026
- Decision date (initial)
- 2023-12-04
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 21.0 | LLT | 10052362 | Metastatic colorectal cancer | 10029104 |
| 20.0 | LLT | 10064467 | Urothelial carcinoma | 10029104 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 28.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
| 21.0 | PT | 10061534 | Oesophageal squamous cell carcinoma | 100000004864 |
| 21.1 | LLT | 10049010 | Carcinoma hepatocellular | 10029104 |
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
| 23.0 | PT | 10065430 | HER2 positive breast cancer | 100000004864 |
| 20.0 | PT | 10001150 | Adenocarcinoma gastric | 100000004864 |
| 21.0 | LLT | 10056267 | Gastroesophageal cancer | 10029104 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
| 21.0 | LLT | 10028793 | Nasopharyngeal carcinoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Beigene Ltd.
- Sponsor organisation
- Beigene Ltd.
- Address
- Solaris Avenue 94
- City
- Camana Bay
- Postcode
- KY1-1108
- Country
- Cayman Islands
Scientific contact point
- Organisation
- Beigene Ltd.
- Contact name
- BeiGene Clinical Support
Public contact point
- Organisation
- Beigene Ltd.
- Contact name
- BeiGene Clinical Support
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 45 | 3 |
| Rest of world
United States, China, Australia
|
— | 218 | — |
Investigational sites
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Institut De Cancerologie De L Ouest
Medical oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Curie
Department of Drug Development and Innovation, 26 Rue D Ulm, 75005, Paris
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 | 2024-01-08 | 2024-02-15 | 2025-04-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-82709
- Halt date
- 2025-04-29
- Member states concerned
- France
- Publication date
- 2025-05-14
- Reason
- Sponsor decision
- Explanation
- Per article 37 of the Clinical Trial Regulation, the Sponsor informs the member state concerned of a temporary halt due to Sponsor decision. The temporary halt is not due to a change in Patient safety or Benefit risk balance.
- Follow-up measures
- Patients who are currently on treatment or in follow up will continue as per the study protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-09 | France | Acceptable 2023-11-27
|
2023-12-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-09 | France | Acceptable 2024-02-26
|
2024-03-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-27 | France | Acceptable 2024-05-13
|
2024-05-13 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-27 | France | Acceptable 2024-05-13
|
2024-05-27 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-10 | France | Acceptable 2024-05-13
|
2024-09-10 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-20 | France | Acceptable 2024-05-13
|
2024-09-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-13 | France | Acceptable 2025-03-07
|
2025-03-07 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-16 | France | Acceptable 2025-06-11
|
2025-06-17 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-23 | France | Acceptable 2025-11-18
|
2025-11-18 |