Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
699
Countries
6
Sites
14
Triple negative breast 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 Feb 2024 → ongoing
- Decision date (initial)
- 2023-10-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506604-18-00
- EudraCT number
- 2021-003517-19
- ClinicalTrials.gov
- NCT05208762
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Triple negative breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10051971 | Pancreatic adenocarcinoma | 10029104 |
| 21.0 | PT | 10061534 | Oesophageal squamous cell carcinoma | 100000004864 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 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
- Seagen Clinical Trial Information
Public contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Clinical Trial Information
Locations
6 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 24 | 1 |
| France | Ongoing, recruiting | 18 | 3 |
| Germany | Ongoing, recruiting | 35 | 1 |
| Italy | Ongoing, recruiting | 30 | 4 |
| Netherlands | Ongoing, recruiting | 20 | 1 |
| Spain | Ongoing, recruiting | 50 | 4 |
| Rest of world
Canada, Japan, China, United States, United Kingdom
|
— | 522 | — |
Investigational sites
Institut Jules Bordet
Clinical Trial Conduct Unit, Mijlenmeersstraat 90, 1070, Anderlecht
Institut Curie
Medical Oncology, 26 Rue D Ulm, 75005, Paris
Institut Gustave Roussy
Drug Development Department (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Hôpital Saint André
Department of Medical Oncology, 1 rue Jean Burguet, 33075, Bordeaux
Charite Universitaetsmedizin Berlin KöR
Klinik für Hämatologie, Onkologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
European Institute Of Oncology S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Centro Ricerche Cliniche Di Verona S.r.l.
Oncologia Medica, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione IRCCS Istituto Nazionale Dei Tumori
medical oncology, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
medical oncology, Via Pietro Albertoni 15, 40138, Bologna
Netherlands Cancer Institute
Clinical Research Unit (CRU), Plesmanlaan 121, 1066 CX, Amsterdam
Institut Catala D'oncologia
Phase 1 Unit. Breast Cancer Unit, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Quironsalud Barcelona
Medical Oncology, Phase I unit Next Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Hm Sanchinarro
Centro Integral Oncológico Clara Campall, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 |
|---|---|---|---|---|---|
| Belgium | 2023-10-17 | 2023-10-17 | |||
| France | 2023-01-04 | 2023-01-04 | |||
| Germany | 2023-04-04 | 2023-04-04 | |||
| Italy | 2023-05-29 | 2023-05-29 | |||
| Netherlands | 2023-02-02 | 2023-02-02 | |||
| Spain | 2023-03-16 | 2023-03-16 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 6 · Art. 38 CTR
Temporary halt TH-13694
- Halt date
- 2024-02-07
- Member states concerned
- Spain
- Publication date
- 2024-02-13
- Reason
- Sponsor decision
- Explanation
- Protocol stopping criteria triggered by a subject death.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-13692
- Halt date
- 2024-02-07
- Member states concerned
- Italy
- Publication date
- 2024-02-13
- Reason
- Sponsor decision
- Explanation
- Protocol stopping criteria triggered by a subject death.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-13690
- Halt date
- 2024-02-07
- Member states concerned
- Germany
- Publication date
- 2024-02-13
- Reason
- Sponsor decision
- Explanation
- Protocol stopping criteria triggered by a subject death.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-13688
- Halt date
- 2024-02-07
- Member states concerned
- France
- Publication date
- 2024-02-13
- Reason
- Sponsor decision
- Explanation
- Protocol stopping criteria triggered by a subject death.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-13686
- Halt date
- 2024-02-07
- Member states concerned
- Belgium
- Publication date
- 2024-02-13
- Reason
- Sponsor decision
- Explanation
- Protocol stopping criteria triggered by a subject death.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-13696
- Halt date
- 2024-02-07
- Member states concerned
- Netherlands
- Publication date
- 2024-02-13
- Reason
- Sponsor decision
- Explanation
- Protocol stopping criteria triggered by a subject death.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-15 | Belgium | Acceptable 2023-10-05
|
2023-10-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Belgium | Acceptable with conditions 2024-06-07
|
2024-06-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-26 | Belgium | Acceptable with conditions 2024-10-28
|
2024-10-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-04 | Acceptable with conditions 2024-10-28
|
2024-11-04 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-21 | Belgium | Acceptable with conditions 2025-04-16
|
2025-04-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-13 | Acceptable with conditions | 2025-05-28 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-28 | 2025-05-28 | ||
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-11 | 2025-06-11 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-18 | Belgium | Acceptable 2025-08-14
|
2025-08-14 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-09-22 | Acceptable 2025-08-14
|
2025-09-22 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-17 | Acceptable | 2025-11-03 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-05 | Belgium | Acceptable 2026-06-03
|
2026-06-03 |