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

Recruiting now · Phase 1/Phase 2

Conditions studied: Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT06631092

Run by

NEC Bio B.V

People needed

28

Starts

2024-11-20

Expected to finish

2029-12-31

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Medical and surgical history, and diseases
• Patients with a history of any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, based on the Investigator's judgement, provides a reasonable suspicion of a disease or condition that contraindicates the use of the IMP or that might affect the interpretation of the trial results or render the patient at high risk for treatment complications.
• Patients with CTCAE v 5.0 Grade 3 or higher not having resolved to Grade 1 within 6 weeks before Baseline.
• Patients with any significant co-morbidity which, according to the Investigator's judgement, makes patient compliance to trial conditions unlikely.
• Patients with previous malignant disease (other than the tumor disease for this trial) within the last five (5) years (except adequately treated non-melanoma skin cancers and carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least two (2) years prior to Screening, and the patient is deemed to have been cured with no additional therapy required or anticipated to be required.
• Patients who underwent prior organ transplantation, including allogeneic stem cell transplantation.
• Patients with congenital or any other immunodeficiency syndromes, or any active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, except for:
• a. Patients with vitiligo, psoriasis, alopecia not requiring immunosuppressive treatment, are eligible.
• b. Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation), is acceptable.
• Patients with history of uncontrolled intercurrent illness, including but not limited to uncontrolled hypertension (high blood pressure defined as BPD>=140 mmHg or BPS >=90 mmHg despite of combination therapy with diuretic/CCB/ACE or ARB).
• Patients with a known prior hypersensitivity or contraindications to any of the IMPs or any component in its formulations or any other drug scheduled or likely to be given during the trial, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3).
• Patients with severe acute or chronic medical conditions, including
• Immune colitis
• Inflammatory bowel disease
• History of severe vomiting or diarrhea not having resolved to Grade 1 at Baseline
• Immune pneumonitis
• Pulmonary fibrosis
• Psychiatric conditions including recent (within the last year) or active suicidal ideation or behavior
• Laboratory abnormalities that may increase the risk associated with trial participation or trial treatment administration or may interfere with the interpretation of trial results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this trial.
• Patients with a history of small intestine resection surgery or other major gastrointestinal surgery
• Patients with active infection requiring systemic therapy with antibiotics (at both Screening and Baseline).
• Patients with a known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome or multi-drug resistant gram-negative bacteria.
• Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody Screening test positive).
• Patients with increased anesthesiological risk (e.g. known or predicted difficult airway) if general anesthetic is required .
• Patients with increased bleeding risk (e.g. coagulopathies) and patients on anticoagulants.

Where it is running

• University Clinic Erlangen — Erlangen, Germany (enrolling)
• National Center for Tumor Diseases Heidelberg — Heidelberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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