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

NCT06631092 | Recruiting Phase 1 DMC

• 2 other identifiers: NECVAX-NEO1-05-DE2024-512520-11-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Adverse Events

  AEs listed including system organ class, preferred term, severity, causality and other possibly relevant information. Frequency tables (including both patient and event counts) by System Organ Class (SOC) and preferred term (in number and percentage)

  Up to 36 weeks plus 24 months

• Serious Adverse Events

  SAEs listed including system organ class, preferred term, severity, causality and other possibly relevant information. Frequency tables (including both patient and event counts) by System Organ Class (SOC) and preferred term (in number and percentage)

  Up to 36 weeks plus 24 months

• Change from Baseline in Laboratory Parameters

  Laboratory defined units

  Up to 36 weeks plus 24 months

• Change from Baseline in Electrocardiograms

  ECG QT interval

  Up to 36 weeks plus 24 months

Secondary Outcomes (5)

• Antitumor activity

  Up to 36 weeks

• Event-free survival

  Up to 36 weeks plus 24 months

• Invasive disease-free survival

  Up to 36 weeks plus 24 months

• Residual cancer burden

  At week 12

• Pathological complete response

  At week 12

Other Outcomes (3)

• Tumor immune biomarker

  Up to week 12

• Overall survival (OS)

  Up to 36 weeks plus 24 months

• Intestinal microbiome

  Up to week 36

Study Arms (1)

NECVAX-NEO1

EXPERIMENTAL

Personalised neoantigen-targeting oral DNA cancer vaccine

Biological: Oral DNA Vaccine

Interventions

Oral DNA Vaccine BIOLOGICAL

Bacteria-based orally administered personalised neoantigen-targeting cancer vaccine

NECVAX-NEO1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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

Sponsors & Collaborators

• NEC Bio B.V: lead
• NEC Bio Therapeutics: collaborator

Study Sites (2)

University Clinic Erlangen

Erlangen, Germany

RECRUITING

National Center for Tumor Diseases Heidelberg

Heidelberg, Germany

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Vaccines, DNA

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

Central Study Contacts

Heinz Lubenau, Dr

CONTACT

0049 621 950499; info@nec-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

DE (2)