RecruitingPhase 1interventionalRules rewrite

Phase 1: testing ITI-5000 mRNA Vaccine for Triple Negative Breast Cancer (TNBC)

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.

Official registry: https://clinicaltrials.gov/study/NCT07652242 · Immunomic Therapeutics, Inc. · enrollment listed as 60

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ITI-5000 mRNA Vaccine, Pembrolizumab, or ITI-5000 mRNA Vaccine. The registry lists allocation as randomized. 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).

They plan to enroll about 60 people at 4 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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)

Interventions: ITI-5000 mRNA Vaccine, Pembrolizumab, ITI-5000 mRNA Vaccine, Olaparib, Capecitabine, ITI-5000 MTD (Maximum Tolerated Dose)

Primary outcome (registry wording): Incidence of Dose-Limiting Toxicities as Assessed by CTCAE v5.0

Who it is for (from inclusion criteria)

Ages 18 Years to any
Women only
Applicable to Part A only. Participants must have completed adjuvant pembrolizumab if they were receiving it before enrolling in the study
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
Adults aged 18 years or over
Participants provided a signed and dated ICF
Participant agrees not to receive any routine vaccinations until at least 30 days after receiving the last study vaccine
a. Concurrent endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression) is not permitted during study participation. Concurrent CDK4/6 inhibitors (ribociclib/abemaciclib) are not allowed
Applicable to Part A only. Participants with more than 4 weeks since last active therapy (chemotherapy, radiation therapy, or surgery) and 36 months or less following definitive surgery, based on the period of highest risk for recurrence in participants with stages 2-3 TNBC

Who the registry excludes

Applicable to Part B only. Participant discontinued prior treatment with an ICI due to irAEs
Participant underwent major surgery within 4 weeks before the planned day of vaccination #1 or received any other investigational drug or device within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the planned day of Vaccination #1
Participant has toxicities due to prior chemotherapy that have not been resolved or considered stable and clinically manageable (e.g., neuropathies). Participants with any cardiac toxicities will be excluded
Participant has a significant medical illness, underlying health condition, or abnormal laboratory finding that, in the investigator's opinion, would increase the risk of participating in the study
Participants with an active autoimmune disease requiring immunosuppressive treatment within the last year (excluding irAEs), such as chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more)
Female participants who are trying to conceive, are pregnant, or lactating
A positive serum pregnancy test at screening and/ or a positive human chorionic gonadotropin (hCG) urine test at baseline in women of childbearing potential

Public study contact (from the registry)

Scott L Wehage, M.S.

301-968-3501

studyinquiries@immunomix.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

The Angeles Clinic and Research Institute (TACRI) — Los Angeles, California (recruiting)
START Midwest — Grand Rapids, Michigan (recruiting)
Sarah Cannon Research Institute — Nashville, Tennessee (recruiting)
START San Antonio — San Antonio, Texas (recruiting)

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FAQ about this NCT record

Is NCT07652242 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07652242?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07652242?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary