Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
209
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
- 21 May 2025 → 20 Aug 2025
- Decision date (initial)
- 2023-09-04
- 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 |
|---|---|---|---|---|
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
| 20.0 | LLT | 10064467 | Urothelial carcinoma | 10029104 |
| 22.0 | PT | 10078672 | DNA mismatch repair protein gene mutation | 100000004850 |
| 20.0 | PT | 10077888 | Mismatch repair cancer syndrome | 100000004850 |
| 21.0 | LLT | 10015362 | Esophageal cancer | 10029104 |
| 21.0 | LLT | 10007342 | Carcinoma endometrial | 10029104 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10025650 | Malignant melanoma | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 20.1 | LLT | 10017770 | Gastric carcinoma | 10029104 |
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
| 20.1 | LLT | 10079619 | MSI-high | 10029104 |
| 21.1 | LLT | 10064025 | Merkel cell carcinoma | 10029104 |
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 21.0 | LLT | 10007342 | Carcinoma endometrial | 10029104 |
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
| 21.0 | LLT | 10028793 | Nasopharyngeal carcinoma | 10029104 |
| 20.0 | PT | 10027406 | Mesothelioma | 100000004864 |
| 21.0 | PT | 10080669 | DNA mismatch repair deficiency test | 100000004848 |
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 |
|---|---|---|---|
| Spain | Ended | 60 | 3 |
| Rest of world
United States, Australia, China
|
— | 149 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinico Universitario De Valencia
Oncologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncologia, Avenida De Los Reyes Catolicos 2, 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 |
|---|---|---|---|---|---|
| Spain | 2023-10-17 | 2023-10-17 | 2024-05-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-84062
- Halt date
- 2025-05-26
- Member states concerned
- Spain
- Publication date
- 2025-05-26
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Per article 38 of the Clinical Trials Regulation, the Sponsor informs the Member State concerned of a temporary halt in recruitment as part of the Urgent Safety Measure (USM) submitted in CTIS on 22May2025.
- Follow-up measures
- Please refer to the USM (US-83523) and supporting information submitted in CTIS on 22May2025.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-27710
- Halt date
- 2024-05-28
- Member states concerned
- Spain
- Publication date
- 2024-06-04
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- Per article 38 of the Clinical Trials Regulation, the Sponsor informs the Member State concerned of a temporary halt in recruitment as part of the Urgent Safety Measure (USM) submitted in CTIS on 31May2024.
- Follow-up measures
- Please refer to the USM (US-27459) and supporting information submitted in CTIS on 31May2024.
- Benefit-risk balance changed
- Yes
- 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 | 2023-06-13 | Spain | Acceptable 2023-09-04
|
2023-09-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-19 | Spain | Acceptable 2023-10-18
|
2023-10-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-24 | Spain | Acceptable 2023-10-18
|
2023-10-24 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-02-07 | Spain | Acceptable 2023-10-18
|
2024-02-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-22 | Spain | Acceptable 2024-04-08
|
2024-04-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-04 | Spain | Acceptable 2024-08-14
|
2024-08-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-29 | Spain | Acceptable 2025-01-28
|
2025-01-28 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-05-19 | Spain | Acceptable 2025-05-21
|
2025-05-21 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-17 | Spain | Acceptable 2025-07-18
|
2025-07-21 |