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

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

Trial Details

NCT ID
NCT06631092
Phase
PHASE1 / PHASE2
Sponsor
NEC Bio B.V
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Oral DNA Vaccine
Locations (sample)
  • Erlangen, Germany|49.59099,11.00783
  • Heidelberg, Germany|49.40768,8.69079

Key Eligibility Criteria

  • Patients able to understand and follow instructions during the trial.
  • Patients able and willing to give written informed consent, signed and dated.
  • Female and male patients.
  • Patients aged at least 18 years old at the time of ICF signature.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Triple Negative (TNBC) Breast Cancer Trials on Trialify →