NCT06631092

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: NEC Bio B.V · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 or SoC carboplatin/paclitaxel and epirubicin/cyclophosphamide or doxorubicin/cyclophosphamide chemotherapy. Optionally, 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. Personalized NECVAX-NEO1 constructs containing an eukaryotic expression plasmid encoding a series of selected neoantigen epitopes will be manufactured for administration as a patient-specific investigational medicinal product (IMP). The IMP will be administered and as an add-on therapy to the standard of care PD-1 inhibitor therapy. The trial will consist of mainly: Cohort 1 (n=8) * A Screening and Induction period of up to 12 weeks, including the neoantigen selection and manufacturing phase, and first-line treatment with PD-1 inhibitor therapy with epirubicin 90 mg/m2/cyclophosphamide 600 mg/m2 every 3 weeks combined with pembrolizumab 200 mg as standard of care treatment, * A Treatment period of up to 12 weeks with prime and booster administrations of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor pembrolizumab 200 mg every 3 weeks and nab-paclitaxel 125 mg/m2 once a week for 12 weeks up to planned tumor surgery, * An optional prolongation of booster administration of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor up to 24 weeks, and * A Follow-up period of 4 weeks, with an End of Treatment (EoT) visit at Week 16 or at Week 40 (in case of the optional treatment prolongation). * A long-term safety follow-up period (observation period) after EoT for up to 24 months. Cohort 2 (n=4) * A Screening and Induction period of up to 12 weeks, including the neoantigen selection and manufacturing phase, and first-line treatment with PD-1 inhibitor therapy with paclitaxel 80 mg/m2 once weekly/carboplatin on an area under the concentration-time curve of 5 mg per milliliter per minute once weekly over 12 weeks combined with pembrolizumab 200 mg as standard of care treatment, * A Treatment period of up to 12 weeks with prime and booster administrations of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor pembrolizumab 200 mg every 3 weeks and epirubicin 90 mg/m2/cyclophosphamide 600 mg/m2 or doxorubicin 60 mg/m2/cyclophosphamide 600 mg/m2 for 12 weeks up to planned tumor surgery, * An optional prolongation of booster administration of NECVAX-NEO1 in addition to continuation of PD-1 inhibitor up to 24 weeks, and * A Follow-up period of 4 weeks, with an End of Treatment (EoT) visit at Week 16 or at Week 40 (in case of the optional treatment prolongation). * A long-term safety follow-up period (observation period) after EoT for up to 24 months.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Oral DNA Vaccine	Bacteria-based orally administered personalised neoantigen-targeting cancer vaccine

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2024-10-08
• Last updated: 2026-02-20

Locations

2 sites across 1 country: Germany