[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Step Pharma, SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100576510","phase-2-a-phase-2-study-to-assess-stp938-dencatistat-as-a-monotherapy-in-adults-with-high-risk-essential-thrombocythaemia---the-vectra-trial-100576510",false,"NCT06786234","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","Key Inclusion Criteria:\n\n* Adults aged 18 years or older\n* A confirmed diagnosis of ET according to World Health Organisation (WHO) or British Society for Haematology (BSH) criteria.\n* Meeting criteria for high risk ET.\n* Raised platelet count (\\>600 x109\u002FL) requiring cytoreductive therapy.\n* Neutrophil count \\>1.0 x109\u002FL.\n* Either intolerant of or resistant to hydroxycarbamide having met any one of the criteria at any point in their disease whilst receiving hydroxycarbamide.\n* Adequate hepatic function.\n* Adequate blood coagulation parameters.\n* Eastern Cooperative Oncology Group (ECOG) status of 0-2.\n\nKey Exclusion Criteria:\n\n* Subjects currently or recently receiving cytoreductive therapy for the treatment of essential thrombocythaemia (wash out periods apply).\n* 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.\n* Proven or suspected transformation to polycythaemia vera, myelofibrosis, myelodysplasia, acute myeloid leukaemia or another myeloid neoplasm.\n* Known malabsorption syndrome or other condition that may impair absorption of study medication (e.g. gastrectomy).\n* Previous splenectomy.\n* Any uncontrolled intercurrent illness.\n* Immunocompromised subjects with increased risk of opportunistic infections.\n* Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.\n* Pregnant females, breastfeeding females, and women of child bearing age or males not willing to comply with contraceptive requirements.\n* Known hypersensitivity to any of the excipients used in the formulation of the study drug.\n* 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).","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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:\n\n* Does STP938 control platelet counts\n* Does STP938 control platelet counts without inducing unwanted side effects\n\nParticipants will:\n\n* Take STP938 every day for up to 12 months.\n* Visit the clinic once every week for the first month, then every 2 weeks for checkups and tests.\n* Complete a questionnaire about symptoms once a month.",[26],"Essential Thrombocythaemia",[28,29,30,31,32],"Essential Thrombocythemia","High risk","Resistant to or Intolerant of Hydroxycarbamide Therapy","Resistant to or Intolerant of Hydroxyurea Therapy","Oral therapy","RECRUITING","2026-06-13",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":37},"2025-06-18",{"date":41,"type":20},"2028-09-30",{"name":43,"class":44},"Step Pharma, SAS","INDUSTRY",14,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100538952","phase-1-study-of-stp938-dencatistat-in-advanced-solid-tumours-100538952","NCT06297525","Study of STP938 (Dencatistat) in Advanced Solid Tumours","An Open-Label, Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of the CTPS1 Inhibitor STP938 in Adult Subjects With Advanced Solid Tumors, With a Safety Expansion in Advanced CTPS2 Null Ovarian Cancer","Main Inclusion Criteria:\n\n* Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.\n* Male or female aged ≥ 18 years.\n* Advanced disease not curable by available therapies and requires systemic therapy.\n* Histologically confirmed diagnosis of eligible cancer type.\n* Must have tumor tissue available for biomarker testing.\n* Measurable disease (Part 1) and measurable disease per RECIST (Part2)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Life expectancy \\> 3 months as assessed by the Investigator.\n* Adequate organ function (bone marrow, hepatic, renal function and coagulation).\n* All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.\n\nMain Exclusion Criteria:\n\n* Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements.\n* Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression\n* Active malignancy within 2 years of study enrollment\n* Prior radiation within 2 weeks of start of therapy.\n* Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or \\\u003C5 half-lives since completion of previous investigational therapy, whichever is shorter.\n* Uncontrolled intercurrent illness.\n* Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months.\n* Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.\n* Subjects with 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).",{"count":54,"type":20},70,[56],"PHASE1","The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.\n\nThe Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.",[59],"Solid Tumor",{"date":36,"type":37},{"date":62,"type":37},"2024-08-02",{"date":64,"type":20},"2027-05",{"name":43,"class":44},7,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100474850","phase-1-a-phase-12-study-of-stp938-dencatistat-for-adult-subjects-with-relapsedrefractory-b-cell-and-t-cell-lymphomas-100474850","NCT05463263","A Phase 1\u002F2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed\u002FRefractory B-Cell and T-Cell Lymphomas","An Open-Label, First in Human, Phase 1\u002F2 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the CTPS1 Inhibitor STP938 In Adult Subjects With Relapsed\u002FRefractory B-Cell and T-Cell Lymphomas","Main Inclusion Criteria:\n\n* Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.\n* Male or female aged ≥ 18 years.\n* Relapsed\u002Frefractory patients with histologically confirmed diagnosis of B cell or T cell lymphoma\n* Must have received at least 2 prior systemic therapies and have no treatment options known to provide clinical benefit\n* Must have measurable disease per Lugano lymphoma classification except for cutaneous T-cell lymphoma (CTCL) which is measured via International Society for Cutaneous Lymphomas (ISCL)\u002F European Organization of Research and Treatment of Cancer (EORTC).\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Life expectancy \\> 3 months as assessed by the Investigator.\n* Adequate organ function (bone marrow, hepatic, renal function and coagulation).\n* All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.\n\nMain Exclusion Criteria:\n\n* Pregnant or breastfeeding females and women of child bearing potential or males unwilling to comply with contraception requirements.\n* Known carcinomatous meningitis or central nervous system (CNS) involvement with lymphoma.\n* Active malignancy within 2 years of study enrollment\n* Prior radiation or surgical resection of their lymphoma without additional sites of measurable disease outside of the radiation field or subjects who have received prior radiation or surgical resection of their lymphoma ≤2 weeks prior to the first dose of study drug.\n* Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or \\\u003C5 half-lives since completion of previous investigational therapy, whichever is shorter.\n* Uncontrolled intercurrent illness.\n* Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months.\n* Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.\n* Subjects who have received a live vaccine within 30 days prior to study enrollment or whilst participating in the study.\n* Subjects with 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).\n* Subjects who received a severe acute respiratory syndrome coronavirus 2 vaccine ≤3 weeks prior to study drug dosing.",{"count":75,"type":20},180,[56,23],"The Phase 1 part of the study is a dose escalation of STP938 as monotherapy.\n\nThe Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas.",[79,80],"Lymphoma, B-Cell","Lymphoma, T-Cell",{"date":36,"type":37},{"date":83,"type":37},"2022-08-03",{"date":85,"type":20},"2026-12",{"name":43,"class":44},15,""]