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Triple Negative Breast Cancer (TNBC) / ITI-5000 mRNA Vaccine / Capecitabine · Phase 1 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 clinical trial registration for ITI-5000, a self-amplifying RNA vaccine targeting HERV-K and CT83 in triple-negative breast cancer, designed to determine the maximum tolerated dose and safety profile when given alone or combined with pembrolizumab and either olaparib or capecitabine. No results have been posted in this registry record; the study is currently recruiting.
Phase 1, Interventional, Non Randomized, Parallel, Single masking, Treatment purpose. Triple Negative Breast Cancer (TNBC); Female; age from 18 Years. Intervention: Part A, Cohort 1 ITI-5000 1 µg Monotherapy; Part A, Cohort 2 ITI-5000 10 µg Monotherapy; Part B ITI-5000 and Pembrolizumab + Olaparib; Part A, Cohort 3 ITI-5000 Monotherapy Expansion; Part B ITI-5000 and Pembrolizumab+Capecitabine. n = 60. 2 sites: United States.
This is a Phase 1 clinical trial registration for ITI-5000, a self-amplifying RNA vaccine targeting HERV-K and CT83 in triple-negative breast cancer, designed to determine the maximum tolerated dose and safety profile when given alone or combined with pembrolizumab and either olaparib or capecitabine. No results have been posted in this registry record; the study is currently recruiting.
Registry record with no posted results; efficacy data and final safety profile are not yet available. Primary outcome is dose-limiting toxicity only; no clinical efficacy endpoints reported in this record.
This trial will inform the safety profile and maximum tolerated dose of ITI-5000 in TNBC; however, no efficacy data or clinical recommendations can be drawn from a Phase 1 registration record with no posted results. Clinicians should await peer-reviewed publication of safety and any interim efficacy signals before considering implications for practice.
This is a Phase 1 study registration with no posted results; it is designed to establish safety and maximum tolerated dose in a small population, representing early-stage clinical evaluation.
As stated by the source record.
Quoted from the source exactly as published.
This trial will inform the safety profile and maximum tolerated dose of ITI-5000 in TNBC; however, no efficacy data or clinical recommendations can be drawn from a Phase 1 registration record with no posted results. Clinicians should await peer-reviewed publication of safety and any interim efficacy signals before considering implications for practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07652242). This is a study registration, not published results. Lead sponsor: Immunomic Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Triple Negative Breast Cancer (TNBC). Interventions: BIOLOGICAL: ITI-5000 mRNA Vaccine; DRUG: Pembrolizumab; BIOLOGICAL: ITI-5000 mRNA Vaccine; DRUG: Olaparib; DRUG: Capecitabine; BIOLOGICAL: ITI-5000 MTD (Maximum Tolerated Dose). Primary outcome measures: Incidence of Dose-Limiting Toxicities as Assessed by CTCAE v5.0 , 21-28 days after the first vaccination. Brief summary: 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). ITI-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. The study has two parts: * 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. * 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.
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