RecruitingPhase 1Phase 2NCT06631092

Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer

An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 as add-on to First-line Neoadjuvant Anti-PD-1 Monoclonal Antibody Therapy in Patients With Triple-negative Breast Cancer


Sponsor

NEC Bio B.V

Enrollment

28 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Phase I/II, multicenter, open-label, single-arm trial in triple-negative breast cancer patients under first-line neoadjuvant therapy with approved standard of care anti-PD-1 monoclonal antibody (PD-1 inhibitor), epirubicin/cyclophosphamide chemotherapy, and nab-paclitaxel therapy (cohort 1) or SoC carboplatin/paclitaxel and epirubicin/cyclophosphamide or doxorubicin/cyclophosphamide chemotherapy (cohort 2). NECVAX-NEO1 treatment in addition to standard of care anti-PD1 monoclonal antibody therapy can be prolonged after breast cancer surgery for another 24 weeks, according to the investigator's decision taking into consideration the study patient's health status.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine called NECVAX-NEO1 in combination with standard chemotherapy and immunotherapy in people with newly diagnosed, early-stage triple-negative breast cancer (a type that tends to be more aggressive and doesn't respond to hormone therapies). The vaccine is made from proteins unique to each person's tumor. **You may be eligible if...** - You are 18 or older (male or female) - You have been newly diagnosed with stage II or III triple-negative breast cancer - You are a candidate for standard neoadjuvant (pre-surgery) chemotherapy plus immunotherapy - Your tumor is accessible for biopsy and surgery - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have had another cancer in the last 5 years - You have had an organ transplant - You have an active autoimmune disease requiring treatment - You have active HIV, hepatitis B, or hepatitis C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOral DNA Vaccine

Bacteria-based orally administered personalised neoantigen-targeting cancer vaccine


Locations(2)

University Clinic Erlangen

Erlangen, Germany

National Center for Tumor Diseases Heidelberg

Heidelberg, Germany

View Full Details on ClinicalTrials.gov

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NCT06631092


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