Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Temporarily halted
Participants planned
60
Countries
1
Sites
5
Gastro-Entero-Pancreatic Neuroendocrine Neoplasms
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 29 Jan 2025 → ongoing
- Decision date (initial)
- 2024-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508567-75-00
- ClinicalTrials.gov
- NCT06735560
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Gastro-Entero-Pancreatic Neuroendocrine Neoplasms
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Dr Clément BAILLY
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Dr Clément BAILLY
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 60 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Nuclear Medecine, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Hopital Beaujon
Gastro-entérologie et hépatologie, 100 Boulevard Du General Leclerc, 92110, Clichy
Hopital Beaujon
Nuclear Medecine, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Nantes
Institut des Maladies de l’Appareil Digestif, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Hopital Beaujon
Gastro-entérologie et hépatologie, 100 Boulevard Du General Leclerc, 92110, Clichy
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 | 2025-01-29 | 2025-11-04 | 2026-05-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-136956
- Halt date
- 2026-05-28
- Planned restart
- 2026-10-01
- Member states concerned
- France
- Publication date
- 2026-06-02
- Reason
- Medicinal Product related
- Explanation
- New process for the antibody production.
Telix Innovations S.A. is responsible for the submission of the IMPD-Q for 89Zr-DFO-Girentuximab (89Zr-DFO-GmAb / 89Zr-TLX250 solution for intravenous administration) via “IMPD-Q-only application – EU-CT number: 2024-516332-10-00”. - Follow-up measures
- Inclusion temporary stopped.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | France | Acceptable 2024-11-27
|
2024-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-20 | France | Acceptable 2025-09-18
|
2025-10-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-25 | France | Acceptable 2026-05-05
|
2026-05-05 |