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RECRUITING
NCT06786234
PHASE1

A Phase 1 Study to Assess STP938 as a Monotherapy in Adults With High Risk Essential Thrombocythaemia

Sponsor: Step Pharma, SAS

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the drug STP938 works to treat adults with high risk essential thrombocythaemia (ET) who are resistant to, or intolerant of, hydroxycarbamide (also known as hydroxyurea) therapy. The trial will also learn about the safety of STP938. The main questions the trial aims to answer are: * Does STP938 control platelet counts * Does STP938 control platelet counts without inducing unwanted side effects Participants will: * Take STP938 every day for up to 12 months. * Visit the clinic once every week for the first month, then every 2 weeks for checkups and tests. * Complete a questionnaire about symptoms once a month.

Official title: An Open-Label, Phase 1b Study to Evaluate Safety, Tolerability & Preliminary Activity of the CTPS1 Inhibitor STP938 in Adult Subjects With High Risk Essential Thrombocythaemia Who Are Resistant to or Intolerant of Hydroxycarbamide Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-06-18

Completion Date

2027-12-31

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DRUG

STP938

At enrolment all patients will be assigned to a single dose level of STP938 for 4 weeks. After 4 weeks the dose level may be adjusted as needed by the Investigator.

Locations (13)

CHU Brest

Brest, France

Institut Paoli-Calmettes

Marseille, France

CHU Nantes

Nantes, France

CHU Nice

Nice, France

CHU Nîmes

Nîmes, France

Hôpital Saint-Louis

Paris, France

Gustave Roussy

Villejuif, France

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Imperial College London / Hammersmith Hospital

London, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

Cancer and Haematology Centre, Churchill Hospital

Oxford, United Kingdom

University of Southampton Hospital

Southampton, United Kingdom