[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659014":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":78,"studyPopulation":71,"armGroups":79,"interventions":86,"overallOfficials":71,"centralContacts":91,"locations":97,"responsibleParty":207,"collaborators":71,"id":209,"slug":210,"hasResults":211,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":71,"eligibilityCriteria":215,"healthyVolunteers":211,"sex":216,"minAge":217,"maxAge":71,"enrollmentInfo":218,"targetDuration":71,"studyType":221,"phases":222,"briefSummary":224,"conditions":225,"keywords":234,"overallStatus":239,"whyStopped":71,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"SystImmune Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":71},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Participants with Dose-Limiting Toxicities","A DLT is defined as any of the following:\n\n* Grade 4 neutrophil count decreased lasting \\>7 days.\n* Grade ≥3 febrile neutropenia of any duration.\n* Grade ≥3 platelet count decreased with clinically significant hemorrhage.\n* Grade 4 thrombocytopenia lasting \\>72 hours\n* Death not related to disease progression or extraneous cause.\n* Hy's law cases\n* Grade ≥3 infusion-related reactions (IRRs) leading to permanent discontinuation\n* Grade ≥3 non-hematologic toxicities, except for:\n* Grade 3 nausea\u002Fvomiting or diarrhea for \\\u003C72 hours with adequate antiemetic and other supportive care;\n* Grade 3 fatigue for less than 1 week;\n* Grade ≥3 electrolyte abnormality that lasts up to 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical interventions;\n* Grade ≥3 amylase or lipase that is not associated with symptoms or clinical manifestations of pancreatitis and does not require hospitalization","24 months",{"measure":14,"description":15,"timeFrame":12},"Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)","Measuring the number of patients with serious adverse events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)",{"measure":17,"description":18,"timeFrame":12},"Participants with abnormal physical examination findings","Measure the number of participants with abnormal physical examination findings.",{"measure":20,"description":21,"timeFrame":12},"Participants with abnormal lab results","Measure the number of participants with abnormal clinical laboratory values",{"measure":23,"description":24,"timeFrame":12},"Participants with abnormal ECG reading","Patients with abnormal ECG parameters (including the change from-baseline ECG parameters: heart rate \\[HR\\]; PR; QTcF; and QRS intervals \\[∆HR, ∆PR, ∆QTcF, and ∆QRS\\])",{"measure":26,"description":27,"timeFrame":12},"To determine the maximum tolerated dose (MTD) if reached or minimum safe and pharmacologically effective dose (MSED).","The actual number of subjects enrolled and dose levels to be explored in this study will depend on the MTD and\u002For MSED based on DLTs reported during the DLT observation period.",[29,32,35,38,41,44,47,50,53,56,59,62,65,68],{"measure":30,"description":31,"timeFrame":12},"Cmax of SI-B036","Calculate maximum (peak) observed concentration of SI-B036",{"measure":33,"description":34,"timeFrame":12},"Cmax of anti-drug antibodies (ADAs) to SI-B036","Calculate maximum (peak) observed concentration of anti-SI-B036 antibodies",{"measure":36,"description":37,"timeFrame":12},"Tmax of SI-B036","Calculate time of maximum observed concentration of SI-B036",{"measure":39,"description":40,"timeFrame":12},"Tmax of anti-SI-B036 antibodies","Calculate time of maximum observed concentration of anti-SI-B036 antibodies",{"measure":42,"description":43,"timeFrame":12},"AUC(0-8) of SI-B036","Calculate area under the serum concentration-time curve of SI-B036 from time 0 to 8 hours",{"measure":45,"description":46,"timeFrame":12},"AUC(0-8) of anti-SI-B036 antibodies","Calculate area under the serum concentration-time curve of anti-SI-B036 antibodies from time 0 to 8 hours",{"measure":48,"description":49,"timeFrame":12},"AUC(last) of SI-B036","Calculate area under the serum concentration-time curve up of SI-B036 to the last quantifiable time (0 to 8 hours)",{"measure":51,"description":52,"timeFrame":12},"AUC(last) of anti-SI-B036 antibodies","Calculate area under the serum concentration-time curve up of anti-SI-B036 antibodies to the last quantifiable time (0 to 8 hours)",{"measure":54,"description":55,"timeFrame":12},"Overall Response Rate (ORR)","To assess the clinical efficacy of SI-B036 as measured by ORR using RECIST criteria v1.1",{"measure":57,"description":58,"timeFrame":12},"Disease Control Rate (DCR)","To assess the clinical efficacy of SI-B036 as measured by DCR using RECIST criteria v 1.1",{"measure":60,"description":61,"timeFrame":12},"Time To Response (TTR)","To assess the clinical efficacy of SI-B036 as measured by TTR using RECIST criteria v 1.1",{"measure":63,"description":64,"timeFrame":12},"Progression-Free Survival (PFS)","To assess the clinical efficacy of SI-B036 as measured by PFS using RECIST criteria v 1.1",{"measure":66,"description":67,"timeFrame":12},"Overall Survival (OS)","To assess the clinical efficacy of SI-B036 as measured by OS using RECIST criteria v 1.1",{"measure":69,"description":70,"timeFrame":12},"Duration of response (DoR)","To assess the clinical efficacy of SI-B036 as measured by DoR using RECIST criteria v 1.1",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"NA","SEQUENTIAL","TREATMENT",{"masking":77,"maskingDescription":71,"whoMasked":71},"NONE","This study is an open-label, multicenter, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary efficacy of SI-B036 in participants with locally advanced or metastatic solid tumors.",[80],{"label":81,"type":82,"description":83,"interventionNames":84},"Experimental SI-B036 administered Day 1 per cycle","EXPERIMENTAL","SI-B036 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks",[85],"Drug: SI-B036",[87],{"type":88,"name":89,"description":83,"armGroupLabels":90,"otherNames":71},"DRUG","SI-B036",[81],[92],{"name":93,"role":94,"phone":95,"phoneExt":71,"email":96},"Stephanie Yee","CONTACT","425-453-6841","stephanie.yee@systimmune.com",[98,118,134,146,159,175,191],{"facility":99,"status":71,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Yale Cancer Center","New Haven","Connecticut","06510","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-72.92816,41.30815,{"lat":109,"lon":108},[112,115],{"name":113,"role":94,"phone":114,"phoneExt":71,"email":71},"Thomas Ferencz","203-200-3100",{"name":116,"role":117,"phone":71,"phoneExt":71,"email":71},"So Yeon Kim","PRINCIPAL_INVESTIGATOR",{"facility":119,"status":71,"city":120,"state":121,"zip":122,"country":103,"countryCode":104,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Florida Cancer Specialists Lake Nona","Orlando","Florida","32827",{"type":106,"coordinates":124},[125,126],-81.37924,28.53834,{"lat":126,"lon":125},[129,132],{"name":130,"role":94,"phone":71,"phoneExt":71,"email":131},"Stephanie Davis","Stephanie.Davis@scri.com",{"name":133,"role":117,"phone":71,"phoneExt":71,"email":71},"Cesar Perez-Batista",{"facility":135,"status":71,"city":136,"state":121,"zip":137,"country":103,"countryCode":104,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Florida Cancer Specialists Sarasota","Sarasota","34232",{"type":106,"coordinates":139},[140,141],-82.53065,27.33643,{"lat":141,"lon":140},[144],{"name":145,"role":117,"phone":71,"phoneExt":71,"email":71},"Judy Wang",{"facility":147,"status":71,"city":148,"state":149,"zip":150,"country":103,"countryCode":104,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"OU Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73104",{"type":106,"coordinates":152},[153,154],-97.51643,35.46756,{"lat":154,"lon":153},[157],{"name":158,"role":117,"phone":71,"phoneExt":71,"email":71},"Raid Aljumaily",{"facility":160,"status":71,"city":161,"state":162,"zip":163,"country":103,"countryCode":104,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Sarah Cannon Research Institute - Oncology Partners","Nashville","Tennessee","37203",{"type":106,"coordinates":165},[166,167],-86.78444,36.16589,{"lat":167,"lon":166},[170,173],{"name":171,"role":94,"phone":71,"phoneExt":71,"email":172},"Brittany Callaway","Brittany.Callaway@scri.com",{"name":174,"role":117,"phone":71,"phoneExt":71,"email":71},"Melissa Johnson",{"facility":176,"status":71,"city":177,"state":178,"zip":179,"country":103,"countryCode":104,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Mary Crowley Cancer Research","Dallas","Texas","75230",{"type":106,"coordinates":181},[182,183],-96.80667,32.78306,{"lat":183,"lon":182},[186,189],{"name":187,"role":94,"phone":71,"phoneExt":71,"email":188},"Bianca Reyes","bianca.reyes@scri.com",{"name":190,"role":117,"phone":71,"phoneExt":71,"email":71},"Douglas Orr",{"facility":192,"status":71,"city":193,"state":178,"zip":194,"country":103,"countryCode":104,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"MD Anderson","Houston","77030",{"type":106,"coordinates":196},[197,198],-95.36327,29.76328,{"lat":198,"lon":197},[201,205],{"name":202,"role":94,"phone":203,"phoneExt":71,"email":204},"Katharina Mikosh","713-563-6558","kcmeyer@mdanderson.org",{"name":206,"role":117,"phone":71,"phoneExt":71,"email":71},"Aung Naing",{"type":208,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","100659014","phase-1-si-b036-st-101-in-advancedmetastatic-solid-tumors-100659014",false,"NCT07857616","SI-B036-ST-101 in Advanced\u002FMetastatic Solid Tumors","SI-B036-ST-101: A Multicenter, Open-Label, Phase 1\u002F1b, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SI-B036 in Adult Patients With Advanced\u002FMetastatic Solid Tumors That Are Refractory to Standard Therapies","Inclusion Criteria:\n\n* Documented locally advanced or metastatic solid tumor(s) not amenable to curative surgery or radiation and have received at least 1 line of standard therapy, including adjuvant\u002Fneoadjuvant treatment, or whose cancer is considered refractory to the standard of care (SOC) or for which no standard treatment is available.\n* Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V6.0.\n* Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%.\n* Has adequate organ function before enrollment\n\nPART C Additional Inclusion Criteria (Dose Expansion Only)\n\n\\- For immuno-oncology (IO)-exposed non-small cell lung cancer (NSCLC): histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in subjects who are previously exposed to immune checkpoint inhibitor (ICI) therapy (IO-exposed) and whose disease is refractory to standard of care (SOC) therapy or for whom no appropriate standard treatment options are available. In addition, subjects must have received at least one prior line of platinum therapy.\n\nFor IO naïve NSCLC: histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC in subjects who are not previously exposed to ICI therapy. Subjects must also have PD-L1 expression ≥1% (tumor proportion score \\[TPS\\]) as determined by an FDA-approved assay. In addition, subjects must have received at least one prior line of platinum therapy.\n\nFor Melanoma: histologically confirmed unresectable or metastatic melanoma with prior treatment with an immune checkpoint inhibitor regimen and documented disease progression following such therapy.\n\nFor Ovarian Cancer: has histologic documentation of epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed on or after a previous chemotherapy with or without a poly (ADP-ribose) polymerase (PARP) inhibitor. Prior bevacizumab treatment is allowed.\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral drugs such as Ticio such as capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.\n* Received systemic immunostimulatory therapy within 4 weeks prior to the first dose or is still within 5 half-lives of the treatment (whichever is longer).\n* Received immunosuppressive drugs within 2 weeks prior to the first dose. The use of topical, inhaled, and locally injected steroids is permitted.\n* Participants with history of severe heart disease within 6 months before enrollment.\n* Participants with prolonged QT interval (QTcF \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block, or a history of additional risk factors for Torsades de Pointes (TdP) or any current concomitant medication known to prolong the QT\u002FQTc interval or cause TdP.\n* Other malignant tumors were diagnosed within 5 years prior to the first administration.\n* For the dose escalation portion of the study only, participants with a primary diagnosis of lung cancer are excluded.\n* Participants with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]), stroke, or transient ischemic attack (TIA) within 6 months before screening.\n* Participants with active or recent clinically significant bleeding are excluded, or who are at risk of bleeding due to clinically significant platelet abnormalities or coagulopathy, or who require full-dose anticoagulation or high-intensity antiplatelet therapy on high dose nonsteroidal anti-inflammatory drugs (NSAIDs).\n* Active autoimmune diseases and inflammatory diseases. For autoimmune conditions that are active but stable and low-grade on systemic therapy, discussion with the medical monitor is required prior to screening.\n* Participants with advanced\u002Fclinically significant lung diseases, who have a history of noninfectious interstitial lung disease (ILD)\u002Fpneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening, or concurrent pulmonary disease resulting in severe impaired respiratory function.\n* Participants with primary tumors in the central nervous system (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to Screening.\n* Participant with active or untreated hemorrhagic CNS lesions.\n* Participants with a history of anaphylaxis or severe hypersensitivity reactions.\n* Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Subjects with recent surgery, biopsy, or invasive procedures without adequate wound healing prior to study enrollment.\n* Participated in another clinical trial within 4 weeks prior to first dose of study treatment.\n* Participants who are pregnant, breastfeeding, or planning to become pregnant during the study.\n* History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose.\n* Participant with moderate or major hemoptysis history.\n* Participant has tumors invading large blood vessels\n* Other conditions that the Investigator or sponsor believes are not suitable for participating in this clinical trial.","ALL","18 Years",{"count":219,"type":220},424,"ESTIMATED","INTERVENTIONAL",[223],"PHASE1","The objective of the study is to evaluate the safety and tolerability of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.",[226,227,228,229,230,231,232,233],"Locally Advanced \u002FMetastatic Solid Tumors","Locally Advanced \u002F Metastatic Solid Tumors","Metastatic Solid Cancers","Non Small Cell Lung Cancer","Lung Cancer","Melanoma","Ovarian","NSCLC",[235,236,237,238],"PD-L1","VEGFR-2","First in Human","FIH","NOT_YET_RECRUITING","2026-09-30",{"date":242,"type":243},"2026-10-05","ACTUAL",{"date":245,"type":220},"2026-09",{"date":247,"type":220},"2029-10",{"name":5,"class":6},7]