[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655929":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":33,"overallOfficials":48,"centralContacts":52,"locations":61,"responsibleParty":144,"collaborators":146,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":13,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":13,"enrollmentInfo":158,"targetDuration":13,"studyType":161,"phases":162,"briefSummary":165,"conditions":166,"keywords":175,"overallStatus":64,"whyStopped":13,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluate safety of intratumoral 2141-V11","The primary endpoint of the safety lead-in cohort is safety. Safety is defined as the incidence of dose-limiting toxicities (DLTs) during the 6-week DLT evaluation window.","6 weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21,29],{"label":22,"type":23,"description":24,"interventionNames":25},"Phase Ib","EXPERIMENTAL","Lead-in cohort. The intervention will be considered safe if DLT's are observed in \\\u003C2 of the first 6 patients enrolled; the observation of 2 or more DLTs in the first 6 patients will trigger dose deescalation to dose level -1 (3 mg); should this occur, 6 more patients will be enrolled at dose level -1. If 2 or more DLT's are then observed at dose level -1, the study will be paused and accrual will be stopped to reconsider 2141-V11 dosage.",[26,27,28],"Biological: Intratumoral 2141-V11","Biological: Nivolumab","Drug: Fluoropyrimidine",{"label":30,"type":23,"description":31,"interventionNames":32},"Phase II","Should the intervention prove to be safe, the phase II component can be initiated with an expansion cohort.",[26,27,28],[34,39,43],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":13},"BIOLOGICAL","Intratumoral 2141-V11","2141-V11 is a recombinant fully humanized IgG1 monoclonal antibody directed against CD40, which activates the CD40 receptor.",[30,22],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"Nivolumab","Nivolumab will be given as an intravenous infusion.",[30,22],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"DRUG","Fluoropyrimidine","5-FU will be administered as a continuous infusion over 48 hours",[30,22],[49],{"name":50,"affiliation":5,"role":51},"Samuel Cytryn, MD","PRINCIPAL_INVESTIGATOR",[53,57],{"name":50,"role":54,"phone":55,"phoneExt":13,"email":56},"CONTACT","646-888-4896","CytrynS@mskcc.org",{"name":58,"role":54,"phone":59,"phoneExt":13,"email":60},"Seung Eun Lee, MD","212-639-3754","LeeS25@mskcc.org",[62,78,89,100,112,123,133],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Memorial Sloan Kettering at Basking Ridge (Limited protocol activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-74.54932,40.70621,{"lat":74,"lon":73},[77],{"name":50,"role":54,"phone":55,"phoneExt":13,"email":56},{"facility":79,"status":64,"city":80,"state":66,"zip":81,"country":68,"countryCode":69,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)","Middletown","07748",{"type":71,"coordinates":83},[84,85],-74.11709,40.39428,{"lat":85,"lon":84},[88],{"name":50,"role":54,"phone":55,"phoneExt":13,"email":56},{"facility":90,"status":64,"city":91,"state":66,"zip":92,"country":68,"countryCode":69,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Memorial Sloan Kettering at Bergen (Limited Protocol Activities)","Montvale","07645",{"type":71,"coordinates":94},[95,96],-74.02292,41.04676,{"lat":96,"lon":95},[99],{"name":50,"role":54,"phone":55,"phoneExt":13,"email":56},{"facility":101,"status":64,"city":102,"state":103,"zip":104,"country":68,"countryCode":69,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":71,"coordinates":106},[107,108],-73.29289,40.84288,{"lat":108,"lon":107},[111],{"name":50,"role":54,"phone":55,"phoneExt":13,"email":56},{"facility":113,"status":64,"city":114,"state":103,"zip":115,"country":68,"countryCode":69,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Memorial Sloan Kettering at Westchester (Limited Protocol Activities)","Harrison","10604",{"type":71,"coordinates":117},[118,119],-73.71263,40.96899,{"lat":119,"lon":118},[122],{"name":50,"role":54,"phone":55,"phoneExt":13,"email":56},{"facility":124,"status":64,"city":103,"state":103,"zip":125,"country":68,"countryCode":69,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Memorial Sloan Kettering Cancer Center (All Protocol Activites)","10065",{"type":71,"coordinates":127},[128,129],-74.00597,40.71427,{"lat":129,"lon":128},[132],{"name":50,"role":54,"phone":55,"phoneExt":13,"email":56},{"facility":134,"status":64,"city":135,"state":103,"zip":136,"country":68,"countryCode":69,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Memorial Sloan Kettering at Nassau (Limited protocol activities)","Uniondale","11553",{"type":71,"coordinates":138},[139,140],-73.59291,40.70038,{"lat":140,"lon":139},[143],{"name":50,"role":54,"phone":55,"phoneExt":13,"email":56},{"type":145,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[147],{"name":148,"class":6},"Rockefeller University","100655929","phase-1-a-study-of-2141-v11-in-people-with-esophageal-gastric-or-gastroesophageal-junction-adenocarcinoma-100655929",false,"NCT07818018","A Study of 2141-V11 in People With Esophageal, Gastric, or Gastroesophageal Junction Adenocarcinoma","A Phase 1b\u002FII Study of Intratumoral CD40 Agonist 2141-V11 in Combination With Anti PD-1 and 5-Fluorouracil Therapy in Patients With Advanced Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma\n* Locally advanced unresectable or metastaticdisease at diagnosis\n* On first line systemic therapy including fluoropyrimidine + anti-PD-1 therapy for advanced GEA (e.g. FOLFOX + nivolumab) for a minimum of 3 months and no more than 9 months.\n\n  * Platinum chemotherapy included in first line regimen has been discontinued or will be discontinued ≥2 weeks prior to first planned dose of 2141-V11\n  * Patients in the safety lead-in cohort must be on 5-FU\n* Primary esophageal, gastric, or gastroesophageal junction tumor intact and visible at time of enrollment (within 1 month of 2141-V11 treatment initiation) on endoscopy\n* Evaluable disease at time of 2141-V11 treatment initiation as defined per RECIST v1.1\n* Able to undergo endoscopy\n* Age 18 years or older\n* ECOG performance status 0 to 1 (See Appendix I for performance status criteria)\n* Adequate organ function as defined by:\n\n  * Absolute neutrophil count ≥1000\u002FmcL\n  * Platelets ≥90,000\u002FmcL\n  * Hemoglobin ≥8 g\u002FdL\n  * Serum creatinine ≤1.5X ULN\n  * Serum total bilirubin ≤1.5X ULN OR Direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5X ULN, except patients with Gilbert's disease (≤3X ULN)\n  * AST and ALT ≤3X ULN\n  * Albumin ≥3 mg\u002FdL Abbreviations: ALT, alanine aminotransferase; AST, aminotransferase; ULN, upper limit of normal.\n\nExclusion Criteria:\n\n* Mismatch repair deficient (dMMR) disease by IHC or microsatellite instability (MSI-H) by next-generation sequencing\n* Known HER2-positive disease (IHC 3+ or IHC 2+ and amplification via fluorescence in situ hybridization)\n* Prior radiation therapy to primary esophageal, gastric, or gastroesophageal junction tumor\n* Anti-PD-1 therapy in ongoing regimen has been discontinued for any reason\n* Disease progression on frontline therapy\n* Patients with active autoimmune disease requiring ongoing systemic steroids or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment.\n* Ongoing systemic steroids or receipt of systemic steroid therapy exceeding prednisone 10 mg\u002Fday or equivalent within 7 days before first dose, except physiologic replacement or short-course premedication (e.g. as antiemetics or CT scan contrast premedication), or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.\n* Patients with active infection on parenteral antibiotics\n* Patients with history of grade 3 or higher immune related adverse events to anti-PD-1 therapy may only be enrolled with the permission of the study PI.\n* Prior treatment before ongoing regimen for any reason with PD-1, PD-L1, or CTLA-4 inhibitors\n* Currently participating in a therapeutic study and receiving study therapy or has participated in a therapeutic study within 4 weeks of the first dose of treatment. Radiographic protocols including protocols with experimental tracers are not considered therapeutic studies and are exempt.\n* Known active central nervous system metastases and\u002For leptomeningeal disease\n* HIV, HBV, and HCV testing do not need to be performed as part of the study. For patients with known HIV, HBV, and\u002For HCV infection:\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study","ALL","18 Years",{"count":159,"type":160},30,"ESTIMATED","INTERVENTIONAL",[163,164],"PHASE1","PHASE2","The purpose of this study is to find out whether adding the drug 2141-V11 to standard treatment (anti-PD-1 immunotherapy with or without 5-FU) is a safe treatment approach for participants with advanced esophageal, gastric, or gastroesophageal junction adenocarcinoma",[167,168,169,170,171,172,173,174],"Esophageal Cancer","Advanced Esophageal Cancer","Gastric Cancer","Advanced Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Esophageal Adenocarcinoma","Gastroesophageal Junction Cancer",[167,176,177,170,178,172,179,180,181,5],"advanced esophageal cancer","Gastric cancer","gastroesophageal junction adenocarcinoma","esophageal adenocarcinoma","gastroesophageal junction cancer","26-267","2026-09-08",{"date":184,"type":185},"2026-09-14","ACTUAL",{"date":187,"type":185},"2026-09-04",{"date":189,"type":160},"2029-09-04",{"name":5,"class":6},7]