Actively Recruiting
Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer
Led by NEC Bio B.V · Updated on 2026-02-20
12
Participants Needed
2
Research Sites
266 weeks
Total Duration
On this page
Sponsors
N
NEC Bio B.V
Lead Sponsor
N
NEC Bio Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow trial instructions
- Able and willing to provide written informed consent
- Male or female patients
- At least 18 years old at consent
- Diagnosed with stage II-III triple-negative breast cancer, candidate for neoadjuvant anti-PD1 and anthracycline/taxane chemotherapy
- Tumor accessible for biopsy and surgery with at least 30% tumor cells in biopsy
- Adequate bone marrow function: ANC 1.5 10^9/L (or ANC 1.0 10^9/L if benign cyclical neutropenia), platelets 100 10^9/L, hemoglobin 9 g/dL
- INR < 1.5 ULN (or <3 if on vitamin K antagonist)
- Adequate liver function: total bilirubin 1.5 ULN (or 3 ULN with Gilbert disease), AST and ALT 2.5 ULN (up to 5 ULN if liver metastases)
- Adequate renal function: eGFR 30 mL/min
- Able to undergo MRI/ultrasound imaging
- ECOG performance status 2
- Life expectancy of at least 12 months as judged by investigator
You will not qualify if you...
- History of any disease or condition that contraindicates IMP use or risks treatment complications
- CTCAE grade 3 or higher adverse events not resolved to grade 1 within 6 weeks before baseline
- Significant co-morbidities affecting trial compliance
- Previous malignant disease within 5 years except certain treated skin or in situ cancers unless remission >2 years
- Prior organ transplantation
- Immunodeficiency syndromes or active autoimmune disease that may worsen with immunostimulatory agents, except specified mild conditions
- Uncontrolled intercurrent illnesses including hypertension despite treatment
- Known severe hypersensitivity to IMP components or monoclonal antibodies
- Severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, severe vomiting/diarrhea, immune pneumonitis, pulmonary fibrosis, recent or active suicidal ideation
- Laboratory abnormalities posing increased trial risk
- History of major gastrointestinal surgery
- Active infection requiring systemic antibiotics
- Known HIV, acquired immunodeficiency syndrome, or multi-drug resistant gram-negative bacteria
- Positive hepatitis B or C infection at screening
- Increased anesthesiological or bleeding risk
- Women pregnant, breastfeeding, or not using effective birth control if of childbearing potential
- Males not using effective birth control during study and follow-up
- Known drug or substance abuse
- Recent live vaccines within 30 days prior to treatment
- Participation in other clinical trials within 30 days before screening
- Concurrent treatments interfering with trial
- Chronic concurrent therapy with corticosteroids (except low dose), immunosuppressants, antibiotics, or other anticancer therapies except protocol-specified
- Inability to understand protocol or comply with trial requirements
- Legal incapacity or limited capacity
- Any condition posing undue risk during trial participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Clinic Erlangen
Erlangen, Germany
Actively Recruiting
2
National Center for Tumor Diseases Heidelberg
Heidelberg, Germany
Actively Recruiting
Research Team
H
Heinz Lubenau, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here