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 )
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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 an approved immunotherapy drug called pembrolizumab (Keytruda®), every 21 days for 3 doses total.
Sponsor: Immunomic Therapeutics, Inc.
You may qualify if…
- ✓ Age: Adults aged 18 years or over.
- ✓ Consent: Provided a signed and dated informed consent form (ICF).
- ✓ 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.
- ✓ Prior Treatment: Completed all planned standard therapy (surgery, chemotherapy, radiation, and/or pembrolizumab as applicable) and be within 36 months of definitive surgery.
- ✓ Performance Status: ECOG performance status of 0 or 1.
- ✓ Organ Function: Adequate organ function at baseline (hematology, biochemistry, etc.).
- ✓ 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.
- ✓ 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.
You may not qualify if…
- ✕ Part B only: Discontinued prior treatment with an immune checkpoint inhibitor (ICI) due to immune-related adverse events (irAEs).
- ✕ Recent Surgery/Therapy: Major surgery within 4 weeks before vaccination #1 or received cancer-directed therapy or investigational drug/device within 4 weeks or 5 half-lives before vaccination #1.
- ✕ Part B only: Received other PD-1/PD-L1 inhibitors (besides pembrolizumab) without proper washout.
- ✕ Toxicities: Unresolved toxicities from prior immunotherapy or chemotherapy (must be ≤ Grade 1 or baseline, or deemed irreversible and not worsened by immunotherapy).
- ✕ Medical Illness: Significant medical illness, underlying health condition, or abnormal laboratory finding increasing risk.
- ✕ Autoimmune Disease: Active autoimmune disease requiring immunosuppressive treatment within the last year.
- ✕ Pregnancy/Lactation: Female participants trying to conceive, pregnant, or lactating.
- ✕ Positive Pregnancy Test: Positive serum pregnancy test at screening or positive urine test at baseline.
Where it's recruiting
Grand Rapids
Source: ClinicalTrials.gov · NCT07652242 · last updated 2026-06-17