Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
50
Countries
1
Sites
2
Irresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma
Key facts
- Sponsor
- GE Healthcare Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Jan 2025 → ongoing
- Decision date (initial)
- 2024-07-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515218-42-00
- EudraCT number
- 2022-000246-16
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Irresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
GE Healthcare Limited
- Sponsor organisation
- GE Healthcare Limited
- Address
- Pollards Wood, Nightingales Lane Nightingales Lane
- City
- Chalfont St. Giles
- Postcode
- HP8 4SP
- Country
- United Kingdom
Scientific contact point
- Organisation
- GE Healthcare Limited
- Contact name
- Yaron Raiter
Public contact point
- Organisation
- GE Healthcare Limited
- Contact name
- GE Healthcare
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 50 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Netherlands | 2022-12-05 | 2023-01-27 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-60569
- Halt date
- 2024-11-27
- Member states concerned
- Netherlands
- Publication date
- 2024-12-03
- Reason
- Sponsor decision, Study management related
- Explanation
- Please refer to the attached Sponsor letter sent to site University Medical Center Groningen (PI Dr Derk Jan Groot) to inform about recruitment hold and subsequent actions.
Sponsor would also like to highlight that site “Stichting Amsterdam UMC (AUMC location VUmc)” is not yet active, therefore the trial was ongoing only at site University Medical Center Groningen (Universitair Medisch Centrum Groningen). - Follow-up measures
- Not applicable. No subject is receiving treatment.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Netherlands | Acceptable 2024-07-03
|
2024-07-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-06 | Netherlands | Acceptable 2024-07-03
|
2025-02-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-22 | Netherlands | Acceptable 2025-08-11
|
2025-08-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-05 | Netherlands | Acceptable 2026-03-18
|
2026-03-18 |