Clinical trial • Phase I • Haematology

CTPS1 inhibitor (STP938) for Essential thrombocythaemia | Thrombocythaemia

Phase I trial of CTPS1 inhibitor (STP938) for Essential thrombocythaemia | Thrombocythaemia. open-label, none/not specified-controlled. 10 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Essential thrombocythaemia | Thrombocythaemia
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-02-2025
First CTIS Authorization Date
13-05-2025

Trial design

open-label, none/not specified-controlled Phase I trial across 7 sites in France.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
10

Eligibility

Recruits 10 Vulnerable population selected in CTIS record (isVulnerablePopulationSelected = true); no details provided on consent or assent handling in the available record..

Vulnerable Population
Vulnerable population selected in CTIS record (isVulnerablePopulationSelected = true); no details provided on consent or assent handling in the available record.

Recruitment

Planned Sample Size
13
Recruitment Window Months
24
Consent Approach
Informed consent process not specified in the CTIS record; population described as adult subjects and vulnerable population is selected, but no details on who provides consent, assent procedures, age-specific documents or languages available are provided.

Geography

Total Number Of Sites
7
Total Number Of Participants
13

France

Earliest CTIS Part Ii Submission Date
22-04-2025
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
304
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Institut Gustave Roussy
Department Name
Hématologie Clinique
Principal Investigator Name
Florence PASQUIER
Principal Investigator Email
Florence.PASQUIER@gustaveroussy.fr
Contact Person Name
Florence PASQUIER
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hematology
Principal Investigator Name
Michael LOSCHI
Principal Investigator Email
loschi.m@chu-nice.fr
Contact Person Name
Michael LOSCHI
Contact Person Email
loschi.m@chu-nice.fr
Site Name
Institut de Cancérologie du Gard
Department Name
Hématologie Clinique
Principal Investigator Name
Stefan WICKENHAUSER
Principal Investigator Email
stefan.WICKENHAUSER@chu-nimes.fr
Contact Person Name
Stefan WICKENHAUSER
Site Name
Hôpital Cavale Blanche CHU de Brest
Department Name
Institut de Cancérologie et d’Imagerie
Principal Investigator Name
Jean-Christophe IANOTTO
Principal Investigator Email
jean-christophe.ianotto@chu-brest.fr
Contact Person Name
Jean-Christophe IANOTTO
Site Name
Institut Paoli Calmettes
Department Name
Service d‘Onco-Hématologie
Principal Investigator Name
Jerôme REY
Principal Investigator Email
reyj@ipc.unicancer.fr
Contact Person Name
Jerôme REY
Contact Person Email
reyj@ipc.unicancer.fr
Site Name
Hopital Saint Louis
Department Name
Centre d’investigation Clinique
Principal Investigator Name
Jean-Jacques KILADJIAN
Principal Investigator Email
jean-jacques.kiladjian@aphp.fr
Contact Person Name
Jean-Jacques KILADJIAN
Contact Person Email
jean-jacques.kiladjian@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hématologie Clinique
Principal Investigator Name
Sophie VANTYGHEM
Principal Investigator Email
Sophie.VANTYGHEM@chu-nantes.fr
Contact Person Name
Sophie VANTYGHEM
Contact Person Email
Sophie.VANTYGHEM@chu-nantes.fr

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
STP938
Active Substance
CTPS1 inhibitor (STP938)
Modality
Small molecule

Related trials

Other published trials that may interest you.