[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Loki Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100656553","phase-1-phase-1-trial-of-lm-llo-tt-and-gemcitabine-in-unresectable-pancreatic-ductal-adenocarcinoma-100656553",false,"NCT07828236","PHASE 1 TRIAL OF Lm-LLO-TT AND GEMCITABINE IN UNRESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA","PHASE 1, OPEN-LABEL, FIRST-IN-HUMAN TRIAL OF INTRAPERITONEA L Lm-LLO-TT AND GEMCITABINE IN PARTICIPANTS WITH UNRESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA","Inclusion Criteria:\n\nAble and willing to provide written informed consent. Adults aged 18 years or older. Histologically confirmed pancreatic ductal adenocarcinoma (PDAC) with measurable disease per RECIST v1.1.\n\nPreviously treated with at least one line of chemotherapy for metastatic or unresectable disease, including a fluoropyrimidine-based or gemcitabine-based regimen, or have a contraindication to these therapies.\n\nNo radiation therapy, targeted therapy, or chemotherapy within 14 days prior to first study treatment; no immunotherapy or biologic therapy within 28 days prior to first study treatment.\n\nRecovery to ≤ Grade 2 from clinically significant toxicities of prior therapy. ECOG Performance Status 0-2. Estimated life expectancy greater than 3 months. Adequate organ function, including adequate hematologic, hepatic, and renal function.\n\nParticipants with treated brain metastases may be enrolled if clinically stable for at least 1 month.\n\nWilling to comply with study procedures and contraceptive requirements. Participants with HIV may be enrolled if receiving antiretroviral therapy and CD4 count is \\>400 cells\u002FµL.\n\nParticipants with hepatitis B may be enrolled if viral load is undetectable and appropriately treated; participants with hepatitis C may be enrolled following curative treatment.\n\nDemonstrated tetanus toxoid (TT) immune responsiveness, either at baseline or following administration of a tetanus toxoid booster during screening.\n\nExclusion Criteria:\n\n* History of chronic comorbidities that would significantly limit participation in the study, including severe heart failure (NYHA Class III-IV), end-stage renal disease, substance dependence, or inadequate venous access, as determined by the investigator.\n\nCandidate for curative-intent surgical resection.\n\nSurgery within 2 weeks prior to first study treatment.\n\nEvidence of hepatic cirrhosis or clinically\u002Fradiographically significant ascites.\n\nBlood transfusion within 14 days prior to study treatment or requirement for frequent blood transfusions (\\>2 per month).\n\nTreatment with systemically active corticosteroids within 28 days before study treatment (except low-dose dexamethasone ≤2 mg\u002Fday or prednisone ≤10 mg\u002Fday).\n\nSystemic antibiotic therapy within 14 days prior to first dose of Lm-LLO-TT.\n\nReceipt of another investigational product or vaccine within 28 days prior to first study treatment.\n\nReceipt of any vaccine other than the protocol-required tetanus toxoid booster within 4 weeks before study treatment or during the initial DLT evaluation period.\n\nMajor surgery, significant traumatic injury, unhealed surgical wounds, or planned surgery requiring general anesthesia within 28 days before study treatment.\n\nActive, uncontrolled HIV, hepatitis B, hepatitis C, or HTLV-1 infection, or CD4 count \\\u003C400 cells\u002FµL.\n\nPresence of implanted prosthetic devices, including orthopedic prostheses, pacemakers, or prosthetic heart valves.\n\nChronic immunosuppressive therapy for autoimmune or rheumatologic conditions.\n\nPregnant or breastfeeding individuals.\n\nActive uncontrolled bacterial infection requiring intravenous antibiotics, fever \\>38.1°C, or unexplained fever within 7 days before Day 1.\n\nHistory of Guillain-Barré syndrome within 6 weeks of a previous tetanus toxoid vaccination or prior Arthus-type hypersensitivity reaction to tetanus vaccine.","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","ClinicalTrials.gov Brief Summary\n\nThis Phase 1, open-label, first-in-human study is designed to evaluate the safety, tolerability, and recommended dose of intraperitoneal (IP) administration of Lm-LLO-TT in combination with low-dose gemcitabine in adults with previously treated, unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Up to 18 participants will be enrolled.\n\nLm-LLO-TT is a live attenuated Listeria monocytogenes-based immunotherapy engineered to express a tetanus toxoid antigen. The study will assess the safety of administering Lm-LLO-TT directly into the peritoneal cavity and characterize its use in combination with low-dose gemcitabine.\n\nEligible participants will receive a tetanus toxoid booster vaccination during screening and undergo placement of an intraperitoneal access port before treatment. Participants will receive a single loading dose of Lm-LLO-TT followed by five cycles of low-dose gemcitabine and low-dose Lm-LLO-TT administered over approximately 17 days. Participants will be monitored for adverse events, laboratory abnormalities, dose-limiting toxicities, and disease outcomes throughout the study.\n\nThe primary objective is to assess safety and tolerability and to determine the maximum tolerated dose and recommended dose for future clinical studies. Secondary objectives include evaluation of anti-tumor activity. Exploratory objectives include assessment of immune biomarkers, changes in pancreatic cancer-related symptoms, and changes in pain medication use.\n\nParticipants will undergo tumor imaging assessments following treatment and during follow-up. A post-treatment tumor biopsy will be required for the first 10 enrolled participants and optional for subsequent participants. Participants will be followed for safety, disease status, and survival for up to 6 months after treatment initiation.",[26,27,28],"Pancreas Cancer, Duct Cell Adenocarcinoma","Pancreatic Cancer","Advanced Pancreatic Adenocarcinoma",[30,31,32,33,34,35,36,37],"Unresectable Pancreatic Cancer","cancer immunotherapy","Lm-LLO-TT","tetanus toxoid","Listeria","Gemcitabine","Memory T-cells","Listeria monocytogenes Immunotherapy","NOT_YET_RECRUITING","2026-09-14",{"date":41,"type":42},"2026-09-18","ACTUAL",{"date":44,"type":20},"2026-10-15",{"date":46,"type":20},"2029-01-30",{"name":48,"class":49},"Loki Therapeutics, Inc.","INDUSTRY",""]