Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
150
Countries
4
Sites
19
patients with active brain metastases, where the primary tumour has confirmed BRCA1/2 and/or HRR alterations
Key facts
- Sponsor
- Duke Street Bio Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 23 Oct 2024 → ongoing
- Decision date (initial)
- 2025-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
patients with active brain metastases, where the primary tumour has confirmed BRCA1/2 and/or HRR alterations
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
| 20.0 | LLT | 10006128 | Brain metastases | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Duke Street Bio Limited
- Sponsor organisation
- Duke Street Bio Limited
- Address
- 2 Duke Street
- City
- London
- Postcode
- W1U 3EH
- Country
- United Kingdom
Scientific contact point
- Organisation
- Duke Street Bio Limited
- Contact name
- Dónal Landers
Public contact point
- Organisation
- Duke Street Bio Limited
- Contact name
- Dónal Landers
Locations
4 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 8 | 2 |
| Hungary | Ongoing, recruiting | 5 | 1 |
| Poland | Authorised, recruitment pending | 28 | 5 |
| Spain | Ongoing, recruiting | 60 | 11 |
| Rest of world
United States, India
|
— | 49 | — |
Investigational sites
Institut Godinot
Oncologie médicale, 1 Rue Du General Koenig, 51100, Reims
Institut Bergonie
Oncologie médicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Orszagos Onkologiai Intezet
Chemotherapy "B", Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Uniwersytecki Szpital Kliniczny W Poznaniu
Oncology, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Oncology, Ul. Przedzalniana 66, 90-338, Lodz
Uniwersyteckie Centrum Kliniczne
Oncology Clinic, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Early Phase Trial Unit, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Instytut Centrum Zdrowia Matki Polki
Oncology Clinic, Ul. Rzgowska 281/289, 93-338, Lodz
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Hm Nou Delfos
Oncology START Barcelona – HM Nou Delfos, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle De Gregorio Gea 3 1 A Planta, 46009, Valencia
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Fundacion Rioja Salud
Oncology, Calle Piqueras 98, 26006, Logrono
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 | 2025-10-23 | ||||
| Hungary | 2026-04-29 | 2026-05-26 | |||
| Spain | 2024-10-23 | 2024-11-21 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Spain | Acceptable with conditions 2024-09-23
|
2024-09-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-25 | Spain | Acceptable with conditions | 2024-10-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-20 | Spain | Acceptable 2025-03-04
|
2025-03-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-04 | Spain | Acceptable 2025-03-04
|
2025-03-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-10 | Spain | Acceptable | 2025-03-17 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-03-13 | 2025-06-04 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-08 | Spain | Acceptable | 2025-05-30 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-13 | Spain | Acceptable | 2025-06-20 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-17 | Spain | Acceptable 2025-08-27
|
2025-08-28 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-11 | Spain | Acceptable | 2025-09-22 |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-11-27 | Acceptable with conditions 2024-09-23
|
2026-02-05 | |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2025-11-27 | Acceptable with conditions 2024-09-23
|
2026-03-07 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-11 | Spain | Acceptable 2026-05-11
|
2026-05-12 |