[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Immunomic Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100641604","phase-1-phase-1-study-of-a-self-amplifying-rna-vaccine-iti-5000-in-stage-2-3-triple-negative-breast-cancer-100641604",false,"NCT07652242","Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer","A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Standard of Care Adjuvant Therapy in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC)","VITAL-TNBC","Inclusion Criteria:\n\n1. Applicable to Part A only. Participants must have completed adjuvant pembrolizumab if they were receiving it before enrolling in the study.\n2. Applicable to Cohort 3A and Part B only. Participant must have received neoadjuvant chemotherapy with pembrolizumab, then undergone definitive surgery. At the time of surgery, participant must not have achieved pCR.\n3. Applicable to Part B only. Participant is currently receiving or is planned to receive standard of care adjuvant therapy, including pembrolizumab in combination with capecitabine or olaparib in accordance with the FDA-approved label, with ≥3 cycles remaining if receiving 200mg Q3W or ≥2 cycles remaining if receiving 400 mg Q6W at the time of first ITI-5000 dose.\n4. Adults aged 18 years or over.\n5. Participants provided a signed and dated ICF.\n6. Participant agrees not to receive any routine vaccinations until at least 30 days after receiving the last study vaccine.\n7. TNBC diagnosed as pathologic stage 2-3 according to American Joint Committee on Cancer (AJCC) and confirmed by histological examination, e.g., negative for HER2 as defined by ASCO CAP 2023 guidelines. ER and PgR receptor negative by immunohistochemistry. Participants with BRCA mutations will be allowed.\n\n   a. Concurrent endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression) is not permitted during study participation. Concurrent CDK4\u002F6 inhibitors (ribociclib\u002Fabemaciclib) are not allowed.\n8. Applicable to Part A only. Participants with more than 4 weeks since last active therapy (chemotherapy, radiation therapy, or surgery) and 36 months or less following definitive surgery, based on the period of highest risk for recurrence in participants with stages 2-3 TNBC.\n9. Applicable to Part A only. Participants completed all planned previous cancer treatment (e.g., chemotherapy, radiation, therapy, surgery).\n10. Participant's ECOG performance status is 0 or 1.\n11. Participant had no significant ischemic heart disease or myocardial infarction within 3 months before vaccination #1 and has adequate cardiac function during eligibility evaluation, as evidenced by QTc of ≤470 msec for females or ≤450 msec for males assessed by the Fridericia method (QTcF) and evidenced by the average of measurements from triplicate ECGs at the screening visit.\n\n    a. The eligibility of participants with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the sponsor in consultation with the medical monitor.\n12. Participant has an adequate organ function, as evidenced by the following tests conducted within 7 days before enrollment:\n\n    i. Hematology examination (excluding blood transfusion or use of hematopoietic stimulating agents for correction):\n\n1\\. Hemoglobin ≥8.0 g\u002FL 2. Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL 3. Platelet count ≥100 × 109\u002FL ii. Serum biochemistry examination (excluding recent blood transfusion or albumin administration):\n\n1\\. Alanine aminotransferase and AST ≤1.5 times the ULN 2. Alkaline phosphatase ≤2.5 ULN 3. Total bilirubin ≤ 1.5 ULN 4. Serum creatinine ≤1.5 ULN, with creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula) 13. Women of childbearing potential have a negative serum pregnancy test within 3 days before vaccination #1, and they and their partners agree to use highly effective methods of contraception during the study and for 6 months after the last administration of the study drug.\n\na. NOTE: A woman is considered of non-childbearing potential if she has had a documented bilateral oophorectomy, tubal ligation, or hysterectomy, or if she is postmenopausal, defined as ≥12 months of spontaneous amenorrhea without an alternative medical cause (with serum FSH confirmation if \\\u003C55 years old). 14. Participant is able to attend the required study visits and follow-up as required by this protocol.\n\n15\\. Participant is able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines prior to study registration.\n\n16\\. Participant agrees not to use alternative therapies from the time of informed consent through 30 days following vaccination #3. Participants may be asked to complete a \"wash out\" period before vaccination #1 at the principal investigator's discretion to ensure the absence of all alternative therapies.\n\nNOTE: \"Alternative therapies\" refer to non-prescription or non-standard medical interventions used with the intent to treat or prevent cancer or its symptoms, including but not limited to herbal remedies, high-dose dietary supplements marketed for therapeutic benefit, homeopathic preparations, or naturopathic treatments. Routine vitamins, minerals, or supportive care measures not expected to affect immune function may be continued at the investigator's discretion.\n\nExclusion Criteria:\n\n1. Applicable to Part B only. Participant discontinued prior treatment with an ICI due to irAEs.\n2. Participant underwent major surgery within 4 weeks before the planned day of vaccination #1 or received any other investigational drug or device within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the planned day of Vaccination #1.\n\n   i. Applicable to Part A only. Participant received cancer-directed therapy (chemotherapy, radiotherapy, biologic or immunotherapy, etc.) within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the planned day of Vaccination #1. ii. Applicable to Part B only. Participants who received any PD-1 or PD-L1 inhibitor other than pembrolizumab will be excluded unless they have completed a washout period of ≥ 4 weeks or 5 half-lives of that agent (whichever is shorter) before Vaccination #1.\n3. Participant has toxicities due to prior immunotherapy. For the participant to be eligible, these toxicities must either have returned to ≤ Grade 1 or baseline or been deemed irreversible and in the opinion of the investigator not worsened by immunotherapy (e.g., ICI-endocrinopathies). Participants with any cardiac toxicities (regardless of the grade, etc.) will be excluded.\n4. Participant has toxicities due to prior chemotherapy that have not been resolved or considered stable and clinically manageable (e.g., neuropathies). Participants with any cardiac toxicities will be excluded.\n5. Participant has a significant medical illness, underlying health condition, or abnormal laboratory finding that, in the investigator's opinion, would increase the risk of participating in the study.\n6. Participants with an active autoimmune disease requiring immunosuppressive treatment within the last year (excluding irAEs), such as chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more).\n7. Female participants who are trying to conceive, are pregnant, or lactating.\n8. A positive serum pregnancy test at screening and\u002F or a positive human chorionic gonadotropin (hCG) urine test at baseline in women of childbearing potential.\n9. Participant concurrently participates in any other interventional clinical trial.\n10. Participant has known allergies to any of the components of the study vaccine.\n11. Participant has a history of anaphylaxis requiring medical intervention (including severe reactions to other mRNA vaccines, such as those against SARS-COV-2, etc.).\n12. Participant has a history of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to the first dose of study treatment.\n13. Participant has a history of myocarditis or pericarditis.\n14. Participant has symptomatic congestive heart failure according to New York Heart Association (NYHA) classification, Class III or IV (per NYHA Classification), clinically significant cardiac arrhythmia, or a known left ventricular ejection fraction \\\u003C45%.\n15. Participant has a history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) or requires the use during study participation of concomitant medications known or suspected to prolong the QT\u002FQTc interval, with the exception of drugs with low risk of QT\u002FQTc prolongation that are used as standard premedication (e.g., diphenhydramine, famotidine, ondansetron).\n16. Participant received an mRNA or a live virus vaccine within 28 days of the planned vaccination #1. Flu and COVID vaccinations\u002Fboosters are also prohibited within 28 days before the planned day of vaccination #1. Vaccines that do not contain live virus are permitted.\n17. Participant has prior malignancy, except for the following:\n\n    i. adequately treated basal-cell or squamous-cell skin cancer, ii. in situ cervical cancer, iii. any other cancer from which the participant has been disease-free for at least 3 years.\n18. Participant has a history of organ transplant requiring immunosuppression. Participants with unstable human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) are not eligible.\n\n    a. Stable and well controlled HIV\u002FAIDS participants on retroviral therapy, defined as those with no dose change within 4 weeks before the planned day of vaccination #1 and no anticipated dose change, are eligible.\n19. Participant with known active hepatitis B or C are not eligible. Active hepatitis B is defined as a known positive hepatitis B surface antigen (HBsAg) result. Active hepatitis C is defined by a known positive hepatitis C antibody result and known quantitative hepatitis C virus RNA results greater than the lower limits of detection of the assay.\n\n    a. Participants with a history of infection with hepatitis B virus or HCV may enroll if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and\u002For nucleic acid testing.\n20. Participant was assessed by the investigator as being unable or unwilling to comply with the requirements of the treatment schedule and study procedures for any reason.\n21. Participant has a contraindication to IM injections or blood draws.","FEMALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"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 the following approved immunotherapy drugs pembrolizumab (Keytruda) and either olaparib or capecitabine.",[27],"Triple Negative Breast Cancer (TNBC)",[29,30,31,32,33,34,35,36],"TNBC","saRNA","Pembrolizumab","Phase I Clinical Trial","Immunotherapy","HERV-K","First in Human (FIH)","CT83","RECRUITING","2026-07-30",{"date":40,"type":41},"2026-08-03","ACTUAL",{"date":43,"type":21},"2026-06",{"date":45,"type":21},"2028-08",{"name":47,"class":48},"Immunomic Therapeutics, Inc.","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100648780","phase-1-phase-1-first-in-human-fih-open-label-single-arm-ascending-dose-study-to-assess-the-safety-tolerability-and-preliminary-immunogenicity-of-iti-9001-in-japanese-patients-with-japanese-red-cedar-jrc-pollinosis-100648780","NCT07726147","Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis","Phase 1, First in Human (FIH), Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis: A Two-part Design Consisting of an Open-Label, Single-Arm Part A and a Randomized, Double-Blind, Part B","Inclusion Criteria:\n\n1. Signed and dated informed consent form (ICF)\n2. Female of non-childbearing potential or male aged 18-65 years (inclusive). Women are not considered to be of childbearing potential if they have had a hysterectomy or tubal ligation, or are postmenopausal (≥12 months without menstruation, or FSH in postmenopausal range for women \\\u003C55 years)\n3. Confirmed JCP sensitivity by positive skin prick test (wheal diameter ≥3 mm)\n4. Confirmed JCP sensitivity by ImmunoCAP (serum JCP-specific IgE ≥ class 2)\n5. ≥2 year history of seasonal rhinoconjunctivitis symptoms requiring medication upon JCP exposure\n6. Contraception requirements: \\\u003Cbr\\> a. Women of non-childbearing potential: negative serum pregnancy test ≤3 days before first dose \\\u003Cbr\\> b. Men: surgically sterile, or agree to abstinence or use 2 highly effective methods of contraception during study and for 3 months after last dose if partner is of childbearing potential (male condom + oral hormonal contraceptives, intrauterine device, or intrauterine hormone-releasing system)\n7. No significant ischemic heart disease or myocardial infarction within 6 months before first study drug administration; adequate cardiac function at screening (QTcF ≤470 msec for females or ≤450 msec for males; average of triplicate ECGs). Participants with ventricular arrhythmia assessed case-by-case\n8. Willing and able to participate and comply with all study procedures\n\nExclusion Criteria:\n\n1. Women of childbearing potential (do not meet inclusion criterion #2)\n2. Respiratory function: \\\u003Cbr\\> a. Fever ≥38°C (100.4°F) on day of study drug administration \\\u003Cbr\\> b. FEV1 \\\u003C80% as predicted on spirometry \\\u003Cbr\\> c. Current smoker\u002Ftobacco user \\\u003Cbr\\> d. History of asthma requiring daily medication (except exercise-induced or mild intermittent asthma)\n3. Contraindications: \\\u003Cbr\\> a. Known allergy to ITI-9001 components \\\u003Cbr\\> b. Contraindication to intramuscular injections or blood draws \\\u003Cbr\\> c. History of intolerance or severe allergic reaction to previous immunotherapy \\\u003Cbr\\> d. History of anaphylaxis requiring medical intervention (including severe reactions to mRNA vaccines)\n4. Prior\u002Fconcurrent treatments: \\\u003Cbr\\> a. Participation in another therapeutic clinical trial within 30 days before screening \\\u003Cbr\\> b. Prior or current immunotherapy for JCP \\\u003Cbr\\> c. Specific or nonspecific immunotherapy within 1 year prior to screening \\\u003Cbr\\> d. Biologics (e.g., anti-IgE, anti-IL-5, anti-TNFα) \\\u003Cbr\\> e. mRNA vaccine within 28 days before first study drug administration \\\u003Cbr\\> f. Live vaccine within 28 days or inactivated\u002Ftoxoid vaccine within 7 days before first study drug administration \\\u003Cbr\\> g. Chronic (more than 30 days) systemic corticosteroids (inhaled, oral, IM, IV, potent topical) \\\u003Cbr\\> h. Inability\u002Funwillingness to discontinue beta-blockers up to 48 hours before first study drug administration and during the study \\\u003Cbr\\> i. Inability\u002Funwillingness to comply with washout periods for antihistamines and other allergy medications (per Table 3)\n5. Medical history\u002Fcomorbidities: \\\u003Cbr\\> a. Clinically significant abnormalities on physical exam, labs, or medical history that jeopardize safety or validity of results (except HEENT findings consistent with allergic rhinitis) \\\u003Cbr\\> b. Malignant tumor diagnosed or treated within 5 years prior to first study drug administration (except adequately treated non-melanoma skin cancer or carcinoma in situ) \\\u003Cbr\\> c. Congenital or acquired immune deficiency or suppression (e.g., malignancy, infection, chemotherapy, radiation, corticosteroids) \\\u003Cbr\\> d. History of organ transplant, hematologic malignancy, or autoimmune disease \\\u003Cbr\\> e. History of stroke, transient ischemic attack, unstable angina, myocardial infarction within 3 months prior to first study drug administration \\\u003Cbr\\> f. Symptomatic congestive heart failure (NYHA Class III-IV), unstable angina, significant arrhythmia, or LVEF \\\u003C45% \\\u003Cbr\\> g. History of myocarditis or pericarditis \\\u003Cbr\\> h. Risk factors for torsades de pointes or use of medications known to prolong QT\u002FQTc (except low-risk premedications) \\\u003Cbr\\> i. Clinically significant gastrointestinal, renal, hepatic, neurologic, or hematologic disease \\\u003Cbr\\> j. HIV\u002FAIDS, hepatitis B, or hepatitis C infection \\\u003Cbr\\> k. Recurrent sinusitis, urticaria, or angioedema within past 12 months prior to first study drug administration \\\u003Cbr\\> l. Symptomatic overlap with JRC pollinosis requiring regular medications \\\u003Cbr\\> m. Alcohol or drug abuse within 1 year before screening or current dependence","ALL","18 Months","65 Years",{"count":60,"type":21},45,[24],"This is a Phase 1, first-in-human clinical trial to test a new treatment called ITI-9001 for people with allergies to Japanese Red Cedar (JRC) pollen-a common cause of seasonal allergies in Japan. The main goals are to find out if ITI-9001 is safe, how well people tolerate it, and whether it can trigger helpful immune responses.",[64],"Allergen Immunotherapy",[66,67,68,69],"Japanese Red Cedar (JRC) pollinosis","Japanese Cedar Pollen (JCP) allergy","seasonal allergic rhinitis","self-amplifying RNA (saRNA)","2026-07-20",{"date":72,"type":41},"2026-07-24",{"date":74,"type":41},"2026-06-20",{"date":76,"type":21},"2028-02",{"name":47,"class":48},1,""]