Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
300
Countries
3
Sites
5
Pancreatic Neoplasms
Key facts
- Sponsor
- Seagen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Dec 2023 → 17 Mar 2025
- Decision date (initial)
- 2023-08-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502348-11-00
- ClinicalTrials.gov
- NCT05571839
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pancreatic Neoplasms
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
- Juan Pinelli
Public contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Clinical Trial Information
Locations
3 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 15 | 1 |
| Germany | Ended | 15 | 2 |
| Italy | Ended | 15 | 2 |
| Rest of world
Canada, Switzerland, United States, United Kingdom
|
— | 255 | — |
Investigational sites
Charite Research Organisation GmbH
Department of Dermatology, Venerology and Allergology, Chariteplatz 1, Mitte, Berlin
National Center For Tumor Diseases (NCT) Heidelberg
Department of Dermatology and the NCT, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
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 | 2023-12-15 | 2024-11-27 | 2025-03-17 | ||
| Germany | 2024-02-22 | 2024-02-23 | 2025-03-17 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-14 | Germany | Acceptable 2023-08-07
|
2023-08-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-09-28 | Germany | Acceptable | 2023-10-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-09-28 | Acceptable | 2023-10-19 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-11-03 | Acceptable | 2024-02-16 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-02-22 | Germany | Acceptable | 2024-02-22 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-02-29 | Germany | Acceptable 2024-06-03
|
2024-06-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-07-26 | Germany | Acceptable 2024-09-30
|
2024-09-30 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-01-08 | Germany | Acceptable 2025-03-31
|
2025-04-01 |