Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Immunomic Therapeutics, Inc.
Study ID
NCT07652242
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

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

Interventions

  • ITI-5000 mRNA Vaccine — BIOLOGICAL
    Participants receive ITI-5000. Cohort 1 will receive 1 ug of vaccine
  • Pembrolizumab — DRUG
    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.
  • ITI-5000 mRNA Vaccine — BIOLOGICAL
    Participants receive ITI-5000. Cohort 2 will receive 10 ug of vaccine
  • Olaparib — DRUG
    Participants will receive Olaparib in combination with Pembrolizumab and ITI-5000
  • Capecitabine — DRUG
    Participants will receive Capecitabine in combination with Pembrolizumab and ITI-5000
  • ITI-5000 MTD (Maximum Tolerated Dose) — BIOLOGICAL
    Participants receive ITI-5000 Maximum Tolerated Dose (MTD)

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 the following approved immunotherapy drugs pembrolizumab (Keytruda) and either olaparib or capecitabine.

Key Dates

First listed
Jun 17, 2026
Start date
Jun 30, 2026
Status verified
Jul 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: 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.
  • Experimental: 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.
  • Experimental: Part B ITI-5000 and Pembrolizumab + Olaparib
    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 plus Olaparib.
  • Experimental: Part A, Cohort 3 ITI-5000 Monotherapy Expansion
    Participants receive ITI-5000 Maximum Tolerated Dose (MTD) as an intramuscular injection every 28 days for three doses
  • Experimental: Part B ITI-5000 and Pembrolizumab+Capecitabine
    Participants receive ITI-5000 at the dose determined in Part A as an injection every 21 days for three doses. Participants also receive Pembrolizumab 200 mg or 400 mg per FDA-approved package insert plus Capecitabine

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities as Assessed by CTCAE v5.0 [ Time Frame: 21-28 days after the first vaccination ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
START MidwestGrand RapidsMichigan49546
Dr. Lakhani, MD
[email protected]
Nehal Lakhani, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203
Dr. Sarah Premji, MD
[email protected]
Sarah Premji, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Grand Rapids, MI

By research site
START Midwest· Grand Rapids, MISarah Cannon Research Institute· Nashville, TN

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