Clinical trial • Phase I • Oncology

BG-75202 for Advanced and metastatic solid tumors | Hormone receptor-positive HER2-negative breast cancer | Castration-resistant prostate cancer | Metastatic triple-negative breast cancer

Phase I trial of BG-75202 for Advanced and metastatic solid tumors | Hormone receptor-positive HER2-negative breast cancer | Castration-resistant prostate…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced and metastatic solid tumors | Hormone receptor-positive HER2-negative breast cancer | Castration-resistant prostate cancer | Metastatic triple-negative breast cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
25-11-2025
First CTIS Authorization Date
12-03-2026

Trial design

Phase I trial across 9 sites in Italy, Spain.

Target Sample Size
71

Recruitment

Planned Sample Size
71
Recruitment Window Months
123

Geography

Total Number Of Sites
9
Total Number Of Participants
15

Italy

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
29
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Fase 1
Principal Investigator Name
Gennaro Daniele
Principal Investigator Email
gennaro.daniele@policlinicogemelli.it
Contact Person Name
Gennaro Daniele
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Oncologia ed Ematologia - Unità di fase I
Principal Investigator Name
Matteo Simonelli
Principal Investigator Email
matteo.simonelli@cancercenter.humanitas.it
Contact Person Name
Matteo Simonelli
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Dipartimento di Ricerca Traslazionale a supporto dei percorsi oncologici
Principal Investigator Name
Adriano Gravina
Principal Investigator Email
a.gravina@istitutotumori.na.it
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Principal Investigator Name
Giuseppe Curigliano
Principal Investigator Email
giuseppe.curigliano@ieo.it
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it

Spain

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
17
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Ana Mafalda Antunes de Melo e Oliveira
Principal Investigator Email
moliveira@vhio.net
Contact Person Name
Ana Mafalda Antunes de Melo e Oliveira
Contact Person Email
moliveira@vhio.net
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
Jorge Bartolome
Principal Investigator Email
jorge.bartolome@salud.madrid.org
Contact Person Name
Jorge Bartolome
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Principal Investigator Name
Javier Pascual
Principal Investigator Email
Javier.pascual@ibima.eu
Contact Person Name
Javier Pascual
Contact Person Email
Javier.pascual@ibima.eu
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Principal Investigator Name
Fabricio Racca
Principal Investigator Email
mcoll@nextoncology.eu
Contact Person Name
Fabricio Racca
Contact Person Email
mcoll@nextoncology.eu
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Eva Ciruelos
Principal Investigator Email
xxxxxx@xxx.xxx
Contact Person Name
Eva Ciruelos
Contact Person Email
xxxxxx@xxx.xxx

Sponsor

Primary sponsor

Full Name
BeOne Medicines I GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
BG-75202
Combination Treatment
Yes

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