A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Standard of Care Adjuvant Therapy in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC)
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 the following approved immunotherapy drugs pembrolizumab (Keytruda) and either olaparib or capecitabine.
Description
This will be a phase 1, FIH, multicenter, open-label, two-part, ascending dose study to evaluate the safety, tolerability, and immune response of the ITI-5000 vaccine in adult participants with TNBC (stage 2-3). The study will be divided into 2 parts: in Part A, participants will receive the ITI-5000 vaccine as a single agent in the post-adjuvant setting, and in Part B, participants will receive the ITI-5000 vaccine in combination with standard of care adjuvant therapy. Part A will be divided into 2 dose level cohorts - Cohort 1A conducted at the dose of 1 μg (low dose) per vaccination and Co…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Applicable to Part A only. Participants must have completed adjuvant pembrolizumab if they were receiving it before enrolling in the study. 2. Applicable to Cohort 3A and Part B only. Participant must have received neoadjuvant chemotherapy with pembrolizumab, then undergone definitive surgery. At the time of surgery, participant must not have achieved pCR. 3. Applicable to Part B only. Participant is currently receiving or is planned to receive standard of care adjuvant therapy, including pembrolizumab in combination with capecitabine or olaparib in accordance with the…
Interventions
- BiologicalITI-5000 mRNA Vaccine
Participants receive ITI-5000. Cohort 1 will receive 1 ug of vaccine
- DrugPembrolizumab
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.
- BiologicalITI-5000 mRNA Vaccine
Participants receive ITI-5000. Cohort 2 will receive 10 ug of vaccine
- DrugOlaparib
Participants will receive Olaparib in combination with Pembrolizumab and ITI-5000
- DrugCapecitabine
Participants will receive Capecitabine in combination with Pembrolizumab and ITI-5000
- BiologicalITI-5000 MTD (Maximum Tolerated Dose)
Participants receive ITI-5000 Maximum Tolerated Dose (MTD)
Locations (2)
- START MidwestGrand Rapids, Michigan
- Sarah Cannon Research InstituteNashville, Tennessee