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A Phase 1 Study to Assess STP938 as a Monotherapy in Adults With High Risk Essential Thrombocythaemia
Sponsor: Step Pharma, SAS
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
Conditions
Interventions
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