[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538952":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":46,"interventions":57,"overallOfficials":63,"centralContacts":68,"locations":75,"responsibleParty":149,"collaborators":38,"id":151,"slug":38,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":38,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":38,"enrollmentInfo":159,"targetDuration":38,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":38,"overallStatus":78,"whyStopped":38,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Step Pharma, SAS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and Tolerability","Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)","Through study completion, an average of 6 months",[14,18,21,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":17},"Area under the curve (AUC) of STP938","Pharmacokinetic parameter from plasma STP938 levels","9 days",{"measure":19,"description":16,"timeFrame":20},"Maximum plasma concentration (Cmax)","9 Days",{"measure":22,"description":16,"timeFrame":20},"Time to reach maximum concentration (TMax)",{"measure":24,"description":25,"timeFrame":12},"Evaluation of preliminary clinical activity of STP938","Evaluation of ORR using standard response criteria",{"measure":27,"description":28,"timeFrame":12},"Evaluation of best overall response of STP938","Evaluation of best overall response (Complete response \\[CR\\], Partial response \\[PR\\], Stable disease \\[SD\\], Progression of disease \\[PD\\], Not evaluable, Not applicable) using standard response criteria",{"measure":30,"description":31,"timeFrame":12},"Evaluation of Duration of Response","Duration of response (DoR) is defined as the time, in days, from the date measurement criteria that are first met for CR or PR (whichever is first recorded) to the first date that relapse, progressive disease or death, whichever occurs first",{"measure":33,"description":34,"timeFrame":12},"Evaluation of Progression Free Survival","Progression-free survival (PFS) is defined as the time from first STP938 dose to the date of disease progression or death, whichever occurs first",{"measure":36,"description":37,"timeFrame":12},"Change in serum CA125 (ovarian cancer only)","Evaluation of CA125 using standard response criteria",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"NON_RANDOMIZED","SEQUENTIAL","Patients will be assigned to a dose level of STP938 (Phase 1a) or an expansion cohort (Phase 1b) at the time of their enrollment.","TREATMENT",{"masking":45,"maskingDescription":38,"whoMasked":38},"NONE",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Phase 1a (Part 1, Dose Escalation)","EXPERIMENTAL","Up to 5 dose levels with STP938 administered as oral monotherapy",[52],"Drug: STP938",{"label":54,"type":49,"description":55,"interventionNames":56},"Phase 1b (Part 2, Safety Expansion)","Further evaluation of STP938 administered as oral monotherapy at the RP2D",[52],[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":38},"DRUG","STP938","Small molecule",[48,54],[64],{"name":65,"affiliation":66,"role":67},"Maureen Higgins","Step Pharma","STUDY_DIRECTOR",[69,73],{"name":65,"role":70,"phone":71,"phoneExt":38,"email":72},"CONTACT","+33 1 86 26 43 56","STP938-201@step-ph.com",{"name":74,"role":70,"phone":71,"phoneExt":38,"email":72},"Duc Tran",[76,90,100,109,121,132,140],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":38},"Comprehensive Hematology Oncology, LLC","RECRUITING","St. Petersburg","Florida","33709","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-82.67927,27.77086,{"lat":88,"lon":87},{"facility":91,"status":78,"city":92,"state":93,"zip":94,"country":82,"countryCode":83,"cosmosGeoPoint":95,"geoPoint":99,"contacts":38},"Mary Crowley Cancer Research Center","Dallas","Texas","75251",{"type":85,"coordinates":96},[97,98],-96.80667,32.78306,{"lat":98,"lon":97},{"facility":101,"status":78,"city":102,"state":93,"zip":103,"country":82,"countryCode":83,"cosmosGeoPoint":104,"geoPoint":108,"contacts":38},"Next Oncology","San Antonio","78292",{"type":85,"coordinates":105},[106,107],-98.49363,29.42412,{"lat":107,"lon":106},{"facility":110,"status":78,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":38},"Institut Gustave Roussy","Villejuif","Paris","94805","France","FR",{"type":85,"coordinates":117},[118,119],2.35992,48.7939,{"lat":119,"lon":118},{"facility":122,"status":78,"city":123,"state":123,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":38},"The Beatson Institute for Cancer Research","Glasgow","G12 8QQ","United Kingdom","UK",{"type":85,"coordinates":128},[129,130],-4.25763,55.86515,{"lat":130,"lon":129},{"facility":133,"status":78,"city":134,"state":38,"zip":38,"country":125,"countryCode":126,"cosmosGeoPoint":135,"geoPoint":139,"contacts":38},"University College London","London",{"type":85,"coordinates":136},[137,138],-0.12574,51.50853,{"lat":138,"lon":137},{"facility":141,"status":78,"city":142,"state":38,"zip":143,"country":125,"countryCode":126,"cosmosGeoPoint":144,"geoPoint":148,"contacts":38},"The Christie","Manchester","M20 4BX",{"type":85,"coordinates":145},[146,147],-2.23743,53.48095,{"lat":147,"lon":146},{"type":150,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100538952",false,"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).","ALL","18 Years",{"count":160,"type":161},70,"ESTIMATED","INTERVENTIONAL",[164],"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.",[167],"Solid Tumor","2026-06-13",{"date":170,"type":171},"2026-06-16","ACTUAL",{"date":173,"type":171},"2024-08-02",{"date":175,"type":161},"2027-05",{"name":5,"class":6},7]