Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
1,006
Countries
2
Sites
15
Esophageal cancer
Key facts
- Sponsor
- Seagen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Oct 2020 → ongoing
- Decision date (initial)
- 2024-05-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508469-34-00
- EudraCT number
- 2020-001035-27
- ClinicalTrials.gov
- NCT04389632
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Esophageal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 21.0 | LLT | 10033604 | Pancreatic cancer | 10029104 |
| 20.0 | PT | 10040808 | Skin cancer | 100000004864 |
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
| 21.0 | LLT | 10015362 | Esophageal cancer | 10029104 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10005003 | Bladder cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Seagen Inc.
- Sponsor organisation
- Seagen Inc.
- Address
- 21823 30th Drive Southeast
- City
- Bothell
- Postcode
- 98021-3907
- Country
- United States
Scientific contact point
- Organisation
- Seagen Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Seagen Inc.
- Contact name
- Clinical Medical Lead
Locations
2 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 150 | 5 |
| Spain | Ongoing, recruiting | 88 | 10 |
| Rest of world
United States, Switzerland, Korea, Republic of, Canada, Taiwan, United Kingdom
|
— | 768 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
Service d'Oncologie Méicale, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire D'Angers
Service de Pneumologie, 4 Rue Larrey, 49100, Angers
Institut Gustave Roussy
Département d’Innovation Thérapeutique et d’Essais, Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De Lorraine
Département d'Oncologie Médicale, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Centre Antoine Lacassagne
Département d'Oncologie Médicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Hospital Quironsalud Malaga
Oncología Médica, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario Marques De Valdecilla
Servicio de Oncologia, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Ramon Y Cajal
Servicio de Oncología Médica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De Jerez De La Frontera
UGC Oncologia Medica, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Vall D Hebron Institute Of Oncology
Unidad Investigacion Terapia Molecular - VHIO, Calle Natzaret 115, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Quironsalud Barcelona
Oncología Médica. Unidad NEXT Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital General Universitario De Elche
Servicio de Oncología Médica, Edificio 2, Camino De La Almazara 11, Elche
Hospital Universitario Hm Sanchinarro
Unidad de Ensayos Clínicos START Madrid # CIOCC, Calle Ona 10, 28050, Madrid
Hospital Hm Nou Delfos
Unidad de Ensayos Clínicos START Barcelona, Avinguda De Vallcarca 151, 08023, Barcelona
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 | 2020-12-22 | 2021-01-05 | |||
| Spain | 2020-10-14 | 2020-11-16 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-30 | Spain | Acceptable 2024-05-20
|
2024-05-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-01 | Spain | Acceptable 2024-10-24
|
2024-10-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-09 | Spain | Acceptable 2025-04-04
|
2025-04-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-08 | Spain | 2025-04-08 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-12 | Spain | Acceptable 2025-06-24
|
2025-06-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-11 | Spain | Acceptable 2025-08-19
|
2025-08-19 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-06 | Spain | Acceptable 2026-01-14
|
2026-01-14 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-26 | Spain | Acceptable 2026-03-16
|
2026-03-23 |