Clinical trial • Phase I • Oncology

STP938 (CTPS1 inhibitor) for Solid tumor|Ovarian cancer

Phase I trial of STP938 (CTPS1 inhibitor) for Solid tumor|Ovarian cancer. open-label, none/not specified-controlled. 50 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Solid tumor|Ovarian cancer
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
02-08-2024
First CTIS Authorization Date
18-11-2024

Trial design

open-label, none/not specified-controlled Phase I trial across 9 sites in Spain, France.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
50

Recruitment

Planned Sample Size
50
Recruitment Window Months
42

Geography

Total Number Of Sites
9
Total Number Of Participants
20

Spain

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
522
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Centro Integral Oncologico Clara Campal
Principal Investigator Name
Juan José Soto Castillo
Principal Investigator Email
juanj.soto@startmadrid.com
Contact Person Name
Juan José Soto Castillo
Contact Person Email
juanj.soto@startmadrid.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Elena Garralda Cabanas
Principal Investigator Email
egarralda@vhio.net
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Principal Investigator Name
José Alejandro Pérez Fidalgo
Principal Investigator Email
japfidalgo@msn.com
Contact Person Name
José Alejandro Pérez Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Clinica Universidad De Navarra
Department Name
Medical Oncology
Principal Investigator Name
Antonio José González Martín
Principal Investigator Email
agonzalezma@unav.es
Contact Person Name
Antonio José González Martín
Contact Person Email
agonzalezma@unav.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Principal Investigator Name
Alejandro Falcón González
Principal Investigator Email
afalconglez@gmail.com
Contact Person Name
Alejandro Falcón González
Contact Person Email
afalconglez@gmail.com

France

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
547
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Centre Antoine Lacassagne
Department Name
Service d’oncologie
Principal Investigator Name
Philippe Follana
Principal Investigator Email
Philippe.FOLLANA@nice.unicancer.fr
Contact Person Name
Philippe Follana
Site Name
Institut Gustave Roussy
Department Name
DITEP (Département d’Innovation Thérapeutique et d’Essais Précoces)
Principal Investigator Name
Christophe MASSARD
Principal Investigator Email
Christophe.MASSARD@gustaveroussy.fr
Contact Person Name
Christophe MASSARD
Site Name
Institut Bergonie
Department Name
Département d’oncologie médicale
Principal Investigator Name
VERONIQUE DEBIEN
Principal Investigator Email
v.debien@bordeaux.unicancer.fr
Contact Person Name
VERONIQUE DEBIEN
Contact Person Email
v.debien@bordeaux.unicancer.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Service de Gynécologie oncologie
Principal Investigator Name
Thibault De La Motte Rouge
Principal Investigator Email
t.delamotterouge@rennes.unicancer.fr
Contact Person Name
Thibault De La Motte Rouge

Sponsor

Primary sponsor

Full Name
Step Pharma
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
STP938 (CTPS1 inhibitor)
Modality
Small molecule

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