Clinical trial • Phase I • Oncology

DSB2455 for Breast cancer | Ovarian cancer | Metastatic castration-resistant prostate cancer | Brain metastases

Phase I trial of DSB2455 for Breast cancer | Ovarian cancer | Metastatic castration-resistant prostate cancer | Brain metastases.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer | Ovarian cancer | Metastatic castration-resistant prostate cancer | Brain metastases
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
23-09-2024

Trial design

None/Not specified-controlled Phase I trial across 19 sites in Spain, France, Hungary and others.

Comparator
None/Not specified
Biomarker Stratified
True, BRCA1/2 and HRR alterations
Target Sample Size
101

Recruitment

Planned Sample Size
101
Recruitment Window Months
32

Geography

Total Number Of Sites
19
Total Number Of Participants
101

Spain

Earliest CTIS Part Ii Submission Date
01-08-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
650
Number Of Sites
11
Number Of Participants
60

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Contact Person Name
Marcos Iglesias Campos
Contact Person Email
marcos.iglesias@ibima.eu
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
David Lorente Estelles
Contact Person Email
dlorente@fivo.org
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Rosa María Rodríguez Alonso
Contact Person Email
rosarodriguezalonso@gmail.com
Site Name
Hospital Hm Nou Delfos
Department Name
Oncology START Barcelona – HM Nou Delfos
Contact Person Name
Tatiana Hernández Guerrero
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Ramón Yarza Barrio
Contact Person Email
ramon.yarza@startmadrid.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Alejandro Falcón González
Contact Person Email
afalconglez@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Antonio Gonzalez Martin
Contact Person Email
aginzalezma@unav.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Guillermo Antonio De Velasco Oria de Rueda
Contact Person Email
Gdevelasco.gdv@gmail.com
Site Name
Fundacion Rioja Salud
Department Name
Oncology
Contact Person Name
Maria De Miguel
Contact Person Email
maria.demiguel@startrioja.com
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Antonio Gonzalez Martin
Contact Person Email
aginzalezma@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Victoria Sanchez Perez
Contact Person Email
victoriasanchez@vhio.net

France

Earliest CTIS Part Ii Submission Date
27-04-2025
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
380
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Institut Godinot
Department Name
Oncologie médicale
Contact Person Name
Camille Mazza
Site Name
Institut Bergonie
Department Name
Oncologie médicale
Contact Person Name
Diego Teyssonneau

Hungary

Earliest CTIS Part Ii Submission Date
05-01-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
130
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Chemotherapy "B"
Contact Person Name
Gabor Rubovszky
Contact Person Email
rubovszky.gabor@oncol.hu

Poland

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
102
Number Of Sites
5
Number Of Participants
28

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oncology
Contact Person Name
Rodryg Ramlau
Contact Person Email
rramlau@gmail.com
Site Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Department Name
Oncology
Contact Person Name
Wioletta Laszczewska
Contact Person Email
w.laszczewska@ctw.com.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Oncology Clinic
Contact Person Name
Katarzyna Szymczak
Contact Person Email
kszymczak@uck.gda.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Oncology Clinic
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Early Phase Trial Unit
Contact Person Name
Katarzyna Kozak
Contact Person Email
katarzyna.kozak@nio.gov.pl

Sponsor

Primary sponsor

Full Name
Duke Street Bio Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Investigational products

Investigational Product Name
DSB2455

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