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NCT06786234RecruitingPhase 2

A Phase 2 Study to Assess STP938 (Dencatistat) as a Monotherapy in Adults With High Risk Essential Thrombocythaemia - The VECTRA Trial

An Open-Label, Phase 2 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

Source: ClinicalTrials.gov · Last updated 16 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
8 Jan 2025
Start date
18 Jun 2025
Primary completion date
30 Jun 2028
Lead sponsor
Step Pharma, SAS
NCT number
NCT06786234

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 50
  • From 18 Jun 2025 to the primary completion date, 30 Jun 2028
  • 14 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects currently or recently receiving cytoreductive therapy for the treatment of essential thrombocythaemia (wash out periods apply).
  • Subjects who have received any investigational agents for the treatment of essential thrombocythaemia within 4 weeks before enrolment or less than 5 half-lives since completion of prior therapy, whichever is shorter.
  • Previous splenectomy.

Other illness

  • Known malabsorption syndrome or other condition that may impair absorption of study medication (e.g. gastrectomy).
  • Any uncontrolled intercurrent illness.
  • Immunocompromised subjects with increased risk of opportunistic infections.
  • Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.
  • Known hypersensitivity to any of the excipients used in the formulation of the study drug.

Lab values

  • Corrected QT interval \>470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).

Age

  • Pregnant females, breastfeeding females, and women of child bearing age or males not willing to comply with contraceptive requirements.

Other

  • Proven or suspected transformation to polycythaemia vera, myelofibrosis, myelodysplasia, acute myeloid leukaemia or another myeloid neoplasm.

Who the study is looking for

  • Adults aged 18 years or older
  • A confirmed diagnosis of ET according to World Health Organisation (WHO) or British Society for Haematology (BSH) criteria.
  • Meeting criteria for high risk ET.
  • Raised platelet count (\>600 x109/L) requiring cytoreductive therapy.
  • Neutrophil count \>1.0 x109/L.
  • Either intolerant of or resistant to hydroxycarbamide having met any one of the criteria at any point in their disease whilst receiving hydroxycarbamide.
  • Adequate hepatic function.
  • Adequate blood coagulation parameters.
  • Eastern Cooperative Oncology Group (ECOG) status of 0-2.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Brest
Coordinator of this site? Confirm its status
BrestFranceRecruiting
Institut Paoli-Calmettes
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
CHU Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
CHU Nice
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NiceFranceRecruiting
CHU Nîmes
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NîmesFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
Hôpital de la Milétrie, CHU
Coordinator of this site? Confirm its status
PoitiersFranceNot yet recruiting
Gustave Roussy
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VillejuifFranceRecruiting
University Hospital of Wales
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CardiffUnited KingdomRecruiting
Imperial College London - Hammersmith Hospital
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LondonUnited KingdomRecruiting
Sarah Cannon Research Institute
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LondonUnited KingdomRecruiting
Cancer and Haematology Centre, Churchill Hospital
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OxfordUnited KingdomRecruiting
Royal Hallamshire Hospital
Coordinator of this site? Confirm its status
SheffieldUnited KingdomRecruiting
University of Southampton Hospital
Coordinator of this site? Confirm its status
SouthamptonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.