A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Pembrolizumab in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC) Who Have Completed Standard Curative Intent Therapy (VITAL-TNBC Study)
Immunomic Therapeutics, Inc.
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 an approved immunotherapy drug called pembrolizumab (Keytruda®), every 21 days for 3 doses total.
Description
This is a Phase 1, first-in-human (FIH), multicenter, open-label, two-part, ascending-dose study . Part A evaluates ITI-5000 as a single agent using a modified 3+3 dose-escalation design across two sequential cohorts: * Cohort 1: 1 µg (low dose) per vaccination * Cohort 2: 10 µg (high dose) per vaccination Each cohort begins with a sentinel participant monitored for 28 days after Vaccination #1 before additional participants are enrolled. The dose-limiting toxicity (DLT) observation window is Day 1-28 following Vaccination #1. If ≤1/6 participants experience a DLT, the dose is deemed tolerab…
Eligibility
- Age range
- 18+ years