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 )

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Immunomic Therapeutics, Inc.
Study ID
NCT07652242
Phase
PHASE1
Status
Recruiting
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Conditions

  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ITI-5000 TNBC Vaccine — BIOLOGICAL
    For Arms 1 and 2, Participants receive ITI-5000 at two different doses for Part A. Cohort 1 will receive 1 ug of the vaccine. Cohort two, will receive 10 ug of the ITI-5000 Vaccine if the 1 ug dose is tolerated.
  • ITI-5000 TNBC Vaccine + Pembrolizumab — DRUG
    Participants will receive ITI-5000 TNBC vaccine at the MTD (determined in Part A) as an intramuscular injection every 21 days for 3 doses, plus pembrolizumab 200 mg IV Q3W or 400 mg IV Q6W per FDA-approved label.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Feb 29, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Part A, Cohort 1 (ITI-5000 1 µg Monotherapy)
    Participants receive ITI-5000 1 µg as an intramuscular injection every 28 days for 3 doses (Days 1, 29-36, 57-64).
  • Experimental: Arm 2 - Part A, Cohort 2 (ITI-5000 10 ug Monotherapy)
    Participants receive ITI-5000 10 µg as an intramuscular injection every 28 days for 3 doses (Days 1, 29-36, 57-64).
  • Experimental: Arm 3 - Part B (ITI-5000 MTD + Pembrolizumab Combination)
    Participants receive ITI-5000 at the MTD (determined in Part A) as an injection every 21 days for 3 doses, plus pembrolizumab 200 mg IV Q3W or 400 mg IV Q6W per FDA-approved label.

Primary Outcome Measure

Part A: To establish the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of ITI-5000 and to characterize the safety and tolerability of ITI-5000 administered as a single agent. Part B: same as Part A but in combination with Pembrolizumab [ Time Frame: From enrollment to end of treatment at 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
START MidwestGrand RapidsMichigan49546
Nehal Lakahni, MD (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49546

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By research site
START Midwest· Grand Rapids, MI

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