OncoMatch/Clinical Trials/NCT07652242
Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer
Is NCT07652242 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments for triple negative breast cancer (tnbc).
Treatment: ITI-5000 mRNA Vaccine · Pembrolizumab · Olaparib · Capecitabine · ITI-5000 MTD (Maximum Tolerated Dose) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
negative for HER2 as defined by ASCO CAP 2023 guidelines
Required: ESR1 wild-type
ER ... negative by immunohistochemistry
Required: PR (PGR) wild-type
PgR receptor negative by immunohistochemistry
Disease stage
Required: Stage II, III (AJCC)
pathologic stage 2-3 according to American Joint Committee on Cancer (AJCC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Participant's ECOG performance status is 0 or 1
Demographics
Prior therapy
Cannot have received: endocrine therapy (tamoxifen, aromatase inhibitor, ovarian suppression)
Concurrent endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression) is not permitted during study participation
Cannot have received: CDK4/6 inhibitor (ribociclib, abemaciclib)
Concurrent CDK4/6 inhibitors (ribociclib/abemaciclib) are not allowed
Lab requirements
Blood counts
Hemoglobin ≥8.0 g/L; Absolute neutrophil count (ANC) ≥1.0 × 10^9/L; Platelet count ≥100 × 10^9/L
Kidney function
Serum creatinine ≤1.5 ULN, with creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
Liver function
Alanine aminotransferase and AST ≤1.5 times the ULN; Alkaline phosphatase ≤2.5 ULN; Total bilirubin ≤ 1.5 ULN
Cardiac function
QTc ≤470 msec for females or ≤450 msec for males (QTcF, average of triplicate ECGs); no significant ischemic heart disease or myocardial infarction within 3 months before vaccination #1; adequate cardiac function during eligibility evaluation
adequate organ function, as evidenced by the following tests conducted within 7 days before enrollment: Hemoglobin ≥8.0 g/L; ANC ≥1.0 × 10^9/L; Platelet count ≥100 × 10^9/L; Alanine aminotransferase and AST ≤1.5 times the ULN; Alkaline phosphatase ≤2.5 ULN; Total bilirubin ≤ 1.5 ULN; Serum creatinine ≤1.5 ULN, with creatinine clearance ≥ 50 mL/min (Cockcroft-Gault); QTc ≤470 msec for females or ≤450 msec for males (QTcF, average of triplicate ECGs)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- START Midwest · Grand Rapids, Michigan
- Sarah Cannon Research Institute · Nashville, Tennessee
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07652242 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior endocrine therapy, CDK4/6 inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify