[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641604":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":38,"locations":44,"responsibleParty":69,"collaborators":29,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":29,"enrollmentInfo":81,"targetDuration":29,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Immunomic Therapeutics, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A, Cohort 1 ITI-5000 1 µg Monotherapy","EXPERIMENTAL","Participants receive ITI-5000 1 µg as an intramuscular injection every 28 days for 3 doses.",[13],"Biological: ITI-5000 mRNA Vaccine",{"label":15,"type":10,"description":16,"interventionNames":17},"Part A, Cohort 2 ITI-5000 10 µg Monotherapy","Participants receive ITI-5000 10 µg as an intramuscular injection every 28 days for 3 doses.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part B ITI-5000 and Pembrolizumab","Participants receive ITI-5000 at the dose determined in Part A as an injection every 21 days for 3 doses. Participants will also receive pembrolizumab 200 mg or 400 mg per FDA-approved package insert.",[13,22],"Drug: Pembrolizumab",[24,30,35],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","ITI-5000 mRNA Vaccine","Participants receive ITI-5000. Cohort 1 will receive 1 ug of vaccine",[9,19],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DRUG","Pembrolizumab","Participants will receive ITI-5000 as an intramuscular injection every 21 days for 3 doses. Participants will also receive pembrolizumab as per the FDA-approved package insert.",[19],{"type":25,"name":26,"description":36,"armGroupLabels":37,"otherNames":29},"Participants receive ITI-5000. Cohort 2 will receive 10 ug of vaccine",[15],[39],{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},"Scott L Wehage, M.S.","CONTACT","301-968-3501","clinicaloperations@immunomix.com",[45,63],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"START Midwest","RECRUITING","Grand Rapids","Michigan","49546","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-85.66809,42.96336,{"lat":57,"lon":56},[60],{"name":61,"role":62,"phone":29,"phoneExt":29,"email":29},"Nehal Lakahni, MD","PRINCIPAL_INVESTIGATOR",{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},{"type":54,"coordinates":65},[56,57],{"lat":57,"lon":56},[68],{"name":29,"role":41,"phone":29,"phoneExt":29,"email":43},{"type":70,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100641604","phase-1-first-in-human-phase-1-study-of-a-self-amplifying-rna-vaccine-iti-5000-alone-or-in-combination-with-pembrolizumab-in-stage-ii---iii-triple-negative-breast-cancer-following-standard-therapy--vital-tnbc--100641604",false,"NCT07652242","First-in-human, Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) Alone or in Combination With Pembrolizumab in Stage II-- III Triple Negative Breast Cancer Following Standard Therapy ( VITAL-TNBC )","A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Pembrolizumab in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC) Who Have Completed Standard Curative Intent Therapy (VITAL-TNBC Study)","VITAL-TNBC","Inclusion Criteria:\n\n* Age: Adults aged 18 years or over.\n* Consent: Provided a signed and dated informed consent form (ICF).\n* Diagnosis: Histologically confirmed stage 2-3 triple-negative breast cancer (TNBC), defined as HER2-negative, ER-negative, and PgR-negative by immunohistochemistry. BRCA mutations are allowed.\n* Prior Treatment: Completed all planned standard therapy (surgery, chemotherapy, radiation, and\u002For pembrolizumab as applicable) and be within 36 months of definitive surgery.\n* Performance Status: ECOG performance status of 0 or 1.\n* Organ Function: Adequate organ function at baseline (hematology, biochemistry, etc.).\n* Cardiac Function: No significant ischemic heart disease or myocardial infarction within 3 months before vaccination #1; QTc ≤470 msec for females or ≤450 msec for males.\n* Pregnancy: Women of childbearing potential must have a negative serum pregnancy test within 3 days before vaccination #1 and agree to use highly effective contraception during the study and for 123 (Part A) or 137 (Part B) days after last study drug.\n* Compliance: Able to attend required study visits and follow-up.\n* Understanding: Able to understand and provide signed informed consent per IRB\u002FIEC guidelines.\n* Vaccinations: Agrees not to receive routine vaccinations until at least 30 days after the last study vaccine.\n* Alternative Therapies: Agrees not to use alternative therapies from the time of informed consent through 30 days following vaccination #3.\n\nExclusion Criteria:\n\n* Part B only: Discontinued prior treatment with an immune checkpoint inhibitor (ICI) due to immune-related adverse events (irAEs).\n* Recent Surgery\u002FTherapy: Major surgery within 4 weeks before vaccination #1 or received cancer-directed therapy or investigational drug\u002Fdevice within 4 weeks or 5 half-lives before vaccination #1.\n* Part B only: Received other PD-1\u002FPD-L1 inhibitors (besides pembrolizumab) without proper washout.\n* Toxicities: Unresolved toxicities from prior immunotherapy or chemotherapy (must be ≤ Grade 1 or baseline, or deemed irreversible and not worsened by immunotherapy).\n* Medical Illness: Significant medical illness, underlying health condition, or abnormal laboratory finding increasing risk.\n* Autoimmune Disease: Active autoimmune disease requiring immunosuppressive treatment within the last year.\n* Pregnancy\u002FLactation: Female participants trying to conceive, pregnant, or lactating.\n* Positive Pregnancy Test: Positive serum pregnancy test at screening or positive urine test at baseline.\n* Other Trials: Concurrent participation in any other interventional clinical trial.\n* Allergies: Known allergies to any components of the study vaccine.\n* Anaphylaxis: History of anaphylaxis requiring medical intervention (including severe reactions to other mRNA vaccines).\n* Cardiac History: History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to first dose.\n* Myocarditis\u002FPericarditis: History of myocarditis or pericarditis.\n* Heart Failure: Symptomatic congestive heart failure (NYHA Class III or IV), significant arrhythmia, or LVEF \\\u003C45%.\n* QT Risk: History of risk factors for torsade de pointes or use of QT-prolonging medications.\n* Vaccines: Received mRNA or live virus vaccine within 28 days of planned vaccination #1 (flu and COVID boosters prohibited in that window).\n* Prior Malignancy: Prior malignancy except adequately treated basal\u002Fsquamous cell skin cancer, in situ cervical cancer, or disease-free for ≥3 years.\n* Organ Transplant: History of organ transplant requiring immunosuppression; unstable HIV\u002FAIDS.\n* Hepatitis: Known active hepatitis B or C.\n* Compliance: Unable or unwilling to comply with study schedule\u002Fprocedures.\n* Injection\u002FBlood Draw: Contraindication to IM injections or blood draws.","FEMALE","18 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC).\n\nITI-5000 is a self-amplifying RNA (saRNA) vaccine that instructs the immune system to recognize and attack cancer cells expressing two proteins found on TNBC cells-HERV-K and CT83-fused with a molecule called LAMP-1 that helps the immune system respond more strongly. The vaccine is delivered inside lipid nanoparticles (LNPs), similar to other approved mRNA vaccines.\n\nThe study has two parts:\n\n* Part A: Participants receive ITI-5000 alone at one of two dose levels (1 µg or 10 µg), given as an injection into the upper arm muscle every 28 days for 3 doses total. The goal is to find the safest dose.\n* Part B: Participants receive ITI-5000 at the best dose identified in Part A, combined with an approved immunotherapy drug called pembrolizumab (Keytruda®), every 21 days for 3 doses total.",[89],"Triple Negative Breast Cancer (TNBC)",[91,92,32,93,94,95,96,97],"TNBC","saRNA","Phase I Clinical Trial","Immunotherapy","HERV-K","First in Human (FIH)","CT83","2026-06-25",{"date":100,"type":101},"2026-06-29","ACTUAL",{"date":103,"type":83},"2026-06",{"date":105,"type":83},"2028-08",{"name":5,"class":6},2]