A First-in-Human Phase 1 multicenter, open-label Clinical Trial of ITI-5000 in patients with Stage II–III Triple-Negative Breast Cancer (TNBC) as monotherapy and in combination with pembrolizumab (Keytruda)
Latest Information Update: 18 Feb 2026
At a glance
- Drugs ITI 5000 (Primary) ; Pembrolizumab (Primary)
- Indications Triple negative breast cancer
- Focus Adverse reactions; First in man; Therapeutic Use
- Acronyms VITALITI
Most Recent Events
- 18 Feb 2026 New trial record
- 20 Jan 2026 According to an Immunomic Therapeutics media release, the USFDA has cleared the IND application for this trial, and the company expects to begin patient enrollment in Q2 2026 in up to eight U.S. clinical sites.