Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
681
Countries
2
Sites
16
Solid Tumor
Key facts
- Sponsor
- Astellas Pharma Inc
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 May 2024 → ongoing
- Decision date (initial)
- 2023-11-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501590-39-00
- ClinicalTrials.gov
- NCT05382559
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astellas Pharma Inc
- Sponsor organisation
- Astellas Pharma Inc
- Address
- 2 5-1, Nihonbashihoncho Nihonbashihoncho
- City
- Chuo
- Postcode
- 103-8411
- Country
- Japan
Scientific contact point
- Organisation
- Astellas Pharma Inc
- Contact name
- Head RA Clinical Trial Unit
Public contact point
- Organisation
- Astellas Pharma Inc
- Contact name
- Head RA Clinical Trial Unit
Locations
2 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 50 | 5 |
| Spain | Ongoing, recruiting | 40 | 11 |
| Rest of world
Canada, United States, Australia, China, Japan, Korea, Republic of
|
— | 591 | — |
Investigational sites
Centre Hospitalier Lyon Sud
33005: Oncologie Médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Gustave Roussy
33004: DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
33001: Département d'oncologie médica, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
33002: Oncologie Médicale, 229 Cours De L Argonne, 33000, Bordeaux
Centre Hospitalier Universitaire Grenoble Alpes
33003: Unité d'Oncologie Thoracique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Clinica Universidad De Navarra
34011: Medical Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario La Paz
34007: Oncología Médica, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Y Politecnico La Fe
34010: Hematología, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Quironsalud Barcelona
34005: Next Oncology. Phase I Unit, Placa D'alfonso Comin 5-7, 08023, Barcelona
Complexo Hospitalario Universitario A Coruna
34009: Oncologia Médica, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Ramon Y Cajal
34006: Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De La Santa Creu I Sant Pau
34008: Medical Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Virgen De La Macarena
34003: Oncología Médica, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Virgen De La Victoria
34002: Oncología, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitari Vall D Hebron
34001: Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
34004: Oncología Médica, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| France | 2024-05-22 | 2024-05-30 | |||
| Spain | 2024-07-12 | 2024-08-14 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-01 | Spain | Acceptable 2023-11-17
|
2023-11-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-18 | Spain | Acceptable with conditions 2024-06-27
|
2024-06-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-26 | Acceptable with conditions | 2024-08-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-30 | 2024-10-14 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-04 | Spain | Acceptable 2024-12-18
|
2025-01-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-16 | Spain | Acceptable 2025-07-21
|
2025-07-22 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-19 | Spain | Acceptable 2025-07-21
|
2025-08-19 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-01 | Spain | Acceptable | 2025-10-06 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-09 | Spain | 2025-10-09 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-23 | Spain | 2025-12-23 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-12 | Spain | Acceptable 2026-05-25
|
2026-05-28 |