Status:
RECRUITING
A Phase 1 Study to Assess STP938 as a Monotherapy in Adults With High Risk Essential Thrombocythaemia
Lead Sponsor:
Step Pharma, SAS
Conditions:
Essential Thrombocythaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
The aim of the study is to assess a new drug called STP938 for the treatment of essential thrombocythaemia (ET). The study with assess how effective STP938 in treating ET, and also assess any side eff...
Eligibility Criteria
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.
- Proven or suspected transformation to polycythaemia vera, myelofibrosis, myelodysplasia, acute myeloid leukaemia or another myeloid neoplasm.
- Known malabsorption syndrome or other condition that may impair absorption of study medication (e.g. gastrectomy).
- Previous splenectomy.
- 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.
- Pregnant females, breastfeeding females, and women of child bearing age or males not willing to comply with contraceptive requirements.
- Known hypersensitivity to any of the excipients used in the formulation of the study drug.
- 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).
Key Trial Info
Start Date :
June 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06786234
Start Date
June 18 2025
End Date
December 31 2027
Last Update
January 28 2026
Active Locations (13)
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1
CHU Brest
Brest, France
2
Institut Paoli-Calmettes
Marseille, France
3
CHU Nantes
Nantes, France
4
CHU Nice
Nice, France