[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520985":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":60,"studyPopulation":52,"armGroups":61,"interventions":69,"overallOfficials":79,"centralContacts":84,"locations":94,"responsibleParty":136,"collaborators":52,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":52,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":52,"enrollmentInfo":147,"targetDuration":52,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":97,"whyStopped":52,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Stingray Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":52},[9,13],{"measure":10,"description":11,"timeFrame":12},"Frequency and severity of Adverse Events","Adverse events will be graded according to CTCAE v5.0.","From first dose of study drug through 30 days following the last dose of study treatment",{"measure":14,"description":15,"timeFrame":16},"Recommended Phase 2 Dose (RP2D) of SR-8541A","Based on evaluation of Dose Limiting Toxicities (DLT)","From first dose of study drug through 28 days following the first dose of study treatment",[18,21,24,27,30,33,36,40,43,46,49],{"measure":19,"description":20,"timeFrame":16},"Maximum plasma concentration (Cmax)","Cmax measured in ng\u002FmL",{"measure":22,"description":23,"timeFrame":16},"Area under the curve from zero up to time t (AUC0-t)","AUC0-t measured in ng.h\u002FmL",{"measure":25,"description":26,"timeFrame":16},"Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf)","AUC0-inf measured in ng.h\u002FmL",{"measure":28,"description":29,"timeFrame":16},"Maximal time for peak concentration (Tmax)","Tmax measured in h",{"measure":31,"description":32,"timeFrame":16},"Terminal phase rate constant (λz)","λz measured in 1\u002Fh",{"measure":34,"description":35,"timeFrame":16},"Half-life (t1\u002F2)","t1\u002F2 measured in h",{"measure":37,"description":38,"timeFrame":39},"Overall Response Rate","Defined as the proportion of subjects in the efficacy population who achieve a radiographic investigator-assessed confirmed complete response (CR)\u002Fimmune CR (iCR) or partial response (PR)\u002Fimmune PR (iPR) per RECIST v1.1 or immune Response Evaluation Criteria in Solid Tumors (iRECIST) v1.0","From first dose of study drug through 2 years following first dose",{"measure":41,"description":42,"timeFrame":39},"Progression Free Survival","Defined as the time from start of treatment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first",{"measure":44,"description":45,"timeFrame":39},"Duration of Response","Defined as the time from the date a response of PR or better was first recorded to the date on which PD was first noted or the date of death due to any cause",{"measure":47,"description":48,"timeFrame":39},"Disease Control Rate","Defined as the proportion of subjects who achieve an investigator-assessed confirmed CR\u002FiCR, PR\u002FiPR, or Stable Disease (SD)\u002Fimmune SD (iSD) at 16 weeks per RECIST v1.1 or iRECIST v1.0",{"measure":50,"description":51,"timeFrame":39},"Overall Survival","Defined as the time from the start of treatment until death due to any cause",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":52,"timePerspective":52,"maskingInfo":58},"NA","SEQUENTIAL","The study will follow an accelerated titration dose (ATD) escalation scheme. Single-subject cohorts will open sequentially when previous cohort milestones are met, e.g. completion of the Dose-Limiting Toxicity (DLT) period.\n\nIf the single evaluable subject within an ATD cohort experiences a grade ≥ 2 toxicity during the DLT period, the ATD scheme will stop and a traditional 3+3 design will be implemented.\n\nThe combination part will only commence once the SRC has deemed it safe to proceed and a SR-8541A dose from the dose escalation part is selected as the RP2D. The ICI will be either nivolumab or pembrolizumab and dosing will be per SOC. Both investigational products will start on C1D1. Treatment with ICI may be continued if SR-8541A is discontinued and treatment with SR-8541A may be continued after ICI is discontinued.","TREATMENT",{"masking":59,"maskingDescription":52,"whoMasked":52},"NONE","SR-8541A, an ENPP1 inhibitor, will be administered orally as a monotherapy to assess safety, tolerability, and pharmacokinetics (PK) in subjects with advanced\u002Fmetastatic solid tumors.\n\nSubjects eligible for treatment include those whose disease is refractory to standard therapeutic options, or for which there are no standard therapeutic options available.\n\nAll enrolled patients will orally administer SR-8541A daily. Treatment may continue until the subject's disease worsens or another treatment discontinuation criterion is met.\n\nThe combination part will only commence once the SRC has deemed it safe to proceed and a SR-8541A dose from the dose escalation part is selected as the RP2D. The ICI will be either nivolumab or pembrolizumab and dosing will be per SOC. Both investigational products will start on C1D1. Treatment with ICI may be continued if SR-8541A is discontinued and treatment with SR-8541A may be continued after ICI is discontinued.\n\nApproximately 10 subjects will be enrolled.",[62],{"label":63,"type":64,"description":65,"interventionNames":66},"SR-8541A Monotherapy","EXPERIMENTAL","SR-8541A will be orally administered.",[67,68],"Drug: SR-8541A","Drug: Immune checkpoint inhibitor (ICI)",[70,75],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":52},"DRUG","SR-8541A","orally administered ENPP1 inhibitor",[63],{"type":71,"name":76,"description":77,"armGroupLabels":78,"otherNames":52},"Immune checkpoint inhibitor (ICI)","The ICI will be either nivolumab or pembrolizumab.",[63],[80],{"name":81,"affiliation":82,"role":83},"Vinod Ganju, MD","Peninsula & South Eastern Haematology & Oncology Group","PRINCIPAL_INVESTIGATOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":52,"email":89},"Sunil Sharma","CONTACT","602-343-8402","Sunil Sharma \u003Cssharma@honorhealth.com>",{"name":91,"role":87,"phone":92,"phoneExt":52,"email":93},"Jonathan Northrup","317-517-9500","jon@stingraytx.com",[95,112,125],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Scientia Clinical Research Ltd","RECRUITING","Randwick","New South Wales","2031","Australia","AU",{"type":104,"coordinates":105},"Point",[106,107],151.24895,-33.91439,{"lat":107,"lon":106},[110],{"name":111,"role":87,"phone":52,"phoneExt":52,"email":52},"Charlotte Lemech",{"facility":113,"status":97,"city":114,"state":115,"zip":116,"country":101,"countryCode":102,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Monash Health","Clayton","Victoria","3168",{"type":104,"coordinates":118},[119,120],145.11667,-37.91667,{"lat":120,"lon":119},[123],{"name":124,"role":87,"phone":52,"phoneExt":52,"email":52},"Amy Body",{"facility":82,"status":97,"city":126,"state":115,"zip":127,"country":101,"countryCode":102,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Frankston","3199",{"type":104,"coordinates":129},[130,131],145.12291,-38.14458,{"lat":131,"lon":130},[134],{"name":135,"role":87,"phone":52,"phoneExt":52,"email":52},"Vinod Ganju",{"type":137,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100520985","phase-1-a-study-of-sr-8541a-enppi-inhibitor-in-advancedmetastatic-solid-tumors-100520985",false,"NCT06063681","A Study of SR-8541A (ENPPI Inhibitor) in Advanced\u002FMetastatic Solid Tumors","Phase 1, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of SR-8541A (ENPP1 Inhibitor) Administered Orally as Monotherapy or in Combination With Checkpoint Inhibitors in Subjects With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Life expectancy of at least 3 months\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1\n3. Histopathologically\u002Fcytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options.\n4. Measurable disease per RECIST v1.1\n5. Willing to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)\n6. Adequate hematologic, renal and hepatic function\n\nExclusion Criteria:\n\n1. Primary central nervous system (CNS) tumor\n2. Prior systemic anti-cancer treatment including other investigational agents, surgery, or radiation within 28 days or 5 half-lives, whichever is less\n3. Continuous systemic treatment with either corticosteroids (\\>10 milligram \\[mg\\] daily prednisone equivalents) or other immunosuppressive medications within 28 days\n4. Active autoimmune disease that has required systemic treatment in past 2 years\n5. History of documented congestive heart failure (New York Heart Association \\[NYHA\\] class II - IV); unstable angina; poorly controlled hypertension; clinically significant valvular heart disease; high-risk uncontrolled arrhythmias (including sustained ventricular tachycardia); myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the last 6 months, or Canadian Cardiovascular Society angina class \\> 2\n6. Troponin I \\> ULN\n7. Blood pressure (BP) - Systolic \\\u003C 95 mmHg or \\> 160 mmHg or diastolic \\> 100 mmHg\n8. Resting heart rate (HR) \\> 100 beats per minute (BPM)\n9. Corrected QT interval by Fridericia (QTcF) ≥ 470 ms\n10. Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%\n11. Symptomatic uncontrolled CNS disease requiring treatment with steroids or anti-seizure medications within 2 months\n12. Leptomeningeal disease\n13. Spinal cord compression not definitively treated with surgery and\u002For radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 8 weeks\n14. Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment\n15. Prior additional malignancy that is progressing or has received treatment the previous 3 years\n16. Active infection requiring systemic treatment\n17. Positive for human immunodeficiency virus (HIV) (HIV antibodies) or active hepatitis B (e.g., HbsAg reactive) or active hepatitis C (e.g., HCV ribonucleic acid \\[RNA\\] qualitative) infection with detectable viral load\n18. Major surgery within 28 days prior to Day 1 and\u002For minor surgery (excluding biopsy) within 7 days","ALL","18 Years",{"count":148,"type":149},25,"ESTIMATED","INTERVENTIONAL",[152],"PHASE1","This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint inhibitor (ICI) in subjects with solid tumors.",[155],"Advanced \u002F Metastatic Solid Tumor",[157,158,159],"Refractory","Relapsing","Solid Tumors","2025-06-04",{"date":162,"type":163},"2025-06-08","ACTUAL",{"date":165,"type":163},"2023-10-12",{"date":167,"type":149},"2025-12",{"name":5,"class":6},3]