Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
8
Solid Tumours
Key facts
- Sponsor
- T3 Pharmaceuticals AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Jun 2024 → ongoing
- Decision date (initial)
- 2023-11-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504199-19-00
- ClinicalTrials.gov
- NCT05120596
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumours
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
T3 Pharmaceuticals AG
- Sponsor organisation
- T3 Pharmaceuticals AG
- Address
- Klingelbergstrasse 50/70
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- T3 Pharmaceuticals AG
- Contact name
- Clinical Operation
Public contact point
- Organisation
- T3 Pharmaceuticals AG
- Contact name
- Clinical Operation
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 40 | 8 |
| Rest of world
Switzerland, United Kingdom
|
— | 60 | — |
Investigational sites
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Hm Sanchinarro
Phase I trials unit, Calle Ona 10, 28050, Madrid
Hospital Universitario La Paz
Medical Oncology Service, Paseo Castellana 261, 28046, Madrid
Institut Catala D'oncologia
Medical Oncology Service, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Clinica Universidad De Navarra
Medical Immunology and Immunotherapy, Pio XII Etorbidea 36, 31008, Pamplona
Clinica Universidad De Navarra
Medical Immunology and Immunotherapy, Calle Marquesado De Santa Marta 1, 28027, 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 | 2024-06-26 | 2024-07-08 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-06 | Spain | Acceptable 2023-10-30
|
2023-11-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-29 | Spain | Acceptable 2023-12-14
|
2023-12-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-05 | Spain | Acceptable 2024-04-19
|
2024-04-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-17 | Spain | Acceptable 2024-08-29
|
2024-08-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-23 | Spain | Acceptable | 2024-11-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-18 | Spain | Acceptable 2025-02-14
|
2025-02-14 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-24 | Spain | Acceptable 2025-11-25
|
2025-11-27 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-01-30 | Spain | Acceptable 2026-02-18
|
2026-02-20 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-09 | Spain | Acceptable | 2026-03-16 |