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

Launched by STEP PHARMA, SAS · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called STP938 to see if it can effectively treat adults with high-risk essential thrombocythaemia (ET), a condition where the body produces too many platelets, which can lead to serious health problems. The trial aims to find out if STP938 can lower platelet counts without causing harmful side effects, especially in patients who have not responded well to an existing treatment called hydroxycarbamide.

To participate in the trial, individuals must be 18 years or older and have a confirmed diagnosis of high-risk ET with a high platelet count. Participants will take STP938 daily for up to 12 months and will need to visit the clinic regularly for check-ups and tests. They will also complete a monthly questionnaire about their symptoms. This study is not yet recruiting participants, so those interested should keep an eye out for updates.

Gender

ALL

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).