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
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. 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.
• 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.
• cT2-4 N0 or any N-positive (stage II-III) triple-negative breast cancer patients diagnosed as candidates for neoadjuvant anti-PD1 monoclonal antibody and anthracycline/taxane based chemotherapy
• Patients with tumor accessible for biopsy and surgery and showing at least 30% of tumoral cells on the biopsy.
• Patients with adequate bone marrow function at Screening, confirmed at Baseline, including:
∙ ANC ≥ 1.5 × 109/L; patients with documented benign cyclical neutropenia are eligible if white blood cell count is ≥ 1.5 × 109/L, with ANC ≥ 1.0 × 109/L, leukocytes ≥ 4.0 × 109/L, and lymphocytes ≥ 0.6 × 109/L;
‣ platelets ≥ 100 × 109/L;
‣ hemoglobin ≥ 9 g/dL (may have been transfused);
• International Normalized Ratio (INR) \< 1.5×Upper Limit of Normal (ULN); patients treated with vitamin K antagonist are eligible if INR \< 3.
• Patients with adequate hepatic function at Screening, confirmed at Baseline, defined by
∙ total bilirubin level ≤1.5×ULN; patients with documented Gilbert disease are allowed if total bilirubin ≤3×ULN;
‣ aspartate aminotransferase (AST) level ≤2.5×ULN, and alanine aminotransferase (ALT) level ≤2.5×ULN, or, for patients with documented metastatic disease to the liver, AST and ALT levels ≤5×ULN.
⁃ Patients with adequate renal function at Screening, confirmed at Baseline, defined by eGFR ≥ 30 mL/min using 2021 CKD-EPI creatinine equation.
⁃ Patients must be able to undergo MRI/Ultrasound imaging procedures for tumor follow-up.
⁃ Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
⁃ Life expectancy of at least 12 months according to the Investigator's judgement.