Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Temporarily halted
Participants planned
914
Countries
4
Sites
5
Pancreatic carcinoma
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
- 28 Jun 2024 → ongoing
- Decision date (initial)
- 2024-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505858-18-00
- ClinicalTrials.gov
- NCT06131840
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pancreatic carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 26.1 | PT | 10041826 | Squamous cell carcinoma of lung | 100000004864 |
| 21.0 | PT | 10030137 | Oesophageal adenocarcinoma | 100000004864 |
| 21.0 | PT | 10033609 | Pancreatic carcinoma | 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 Trial Information
Public contact point
- Organisation
- Seagen Inc.
- Contact name
- Clinical Trial Information
Locations
4 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 34 | 1 |
| Netherlands | Temporarily halted | 44 | 1 |
| Spain | Temporarily halted | 56 | 2 |
| Sweden | Temporarily halted | 41 | 1 |
| Rest of world
United Kingdom, United States, Japan, Canada, China
|
— | 739 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Clinical Trial Service Unit, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 | 2025-02-11 | 2025-03-06 | 2026-03-20 | ||
| Netherlands | 2024-10-29 | 2024-11-14 | 2026-03-20 | ||
| Spain | 2024-06-28 | 2024-07-12 | 2026-03-20 | ||
| Sweden | 2024-09-05 | 2024-09-18 | 2026-03-20 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-125521
- Halt date
- 2026-03-20
- Member states concerned
- France
- Publication date
- 2026-03-31
- Reason
- Safety related (clinical or pre-clinical results)
- Follow-up measures
- Additional details can be found in the SSC Report and DIL in the USM submitted in CTIS on 25 March 2026 (US125071).
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-125523
- Halt date
- 2026-03-20
- Member states concerned
- Spain
- Publication date
- 2026-03-31
- Reason
- Safety related (clinical or pre-clinical results)
- Follow-up measures
- Additional details can be found in the SSC Report and DIL in the USM submitted in CTIS on 25 March 2026 (US125071).
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-125525
- Halt date
- 2026-03-20
- Member states concerned
- Sweden
- Publication date
- 2026-03-31
- Reason
- Safety related (clinical or pre-clinical results)
- Follow-up measures
- Additional details can be found in the SSC Report and DIL in the USM submitted in CTIS on 25 March 2026 (US125071).
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-125527
- Halt date
- 2026-03-20
- Member states concerned
- Netherlands
- Publication date
- 2026-03-31
- Reason
- Safety related (clinical or pre-clinical results)
- Follow-up measures
- Additional details can be found in the SSC Report and DIL in the USM submitted in CTIS on 25 March 2026 (US125071).
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-02 | France | Acceptable 2024-05-28
|
2024-05-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-04 | Acceptable | 2024-08-22 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-04 | Acceptable | 2024-07-12 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-17 | France | Acceptable 2024-12-11
|
2024-12-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-21 | France | Acceptable 2025-06-11
|
2025-06-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-02 | France | Acceptable 2025-08-13
|
2025-08-13 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-14 | France | Acceptable 2025-08-13
|
2025-10-14 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-08 | France | Acceptable with conditions 2026-03-23
|
2026-03-26 |