Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Anti-PD-1/PD-L1 Therapy in Patients With Solid Tumors

NCT06631079 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: NECVAX-NEO1-02-INT
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 8

Brief Summary

Phase I/II multicenter, open-label, single-arm trial in patients to evaluate the safety and effect of NECVAX-NEO1 administered in combination with PD-1/PD-L1 mABs in patients with solid tumors. Patients with solid tumors who will be treated with approved standard of care (SoC) PD-1 or PD-L1 monoclonal antibody inhibitor therapy, and who after starting treatment with PD-1/PD-L1 inhibitor reached either Stable Disease (SD) or Partial Response (PR) (Cohort 1) or PD (Cohort 2) according to RECIST 1.1 and iRECIST assessed at the Baseline visit may be enrolled in the study

Conditions

Solid Tumor

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 week 24 plus 24 months

• Serious Adverse Events

  Serious 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 week 24 plus 24 months

• Change from Baseline in Laboratory Parameters

  Laboratory Parameter Units

  Up to week 24 plus 24 months

• Change from Baseline in Electrocardiograms

  ECG QT interval

  Up to 24 weeks plus 24 months

Secondary Outcomes (5)

• Antitumor activity

  Up to 24 weeks

• Objective Response Rate

  Up to Week 24 plus 24 months

• Progression free survival

  Up to 24 weeks plus 24 months

• Time to progression

  Up to 24 weeks plus 24 months

• Overall survival

  Up to 24 weeks plus 24 months

Other Outcomes (3)

• Tumor immune biomarker

  Week 24 compared to Screening

• Immune response

  Up to week 24

• Intestinal microbiome

  Up to week 24

Study Arms (1)

NECVAX-NEO1

EXPERIMENTAL

Oral DNA Vaccine

Biological: NECVAX-NEO1

Interventions

NECVAX-NEO1 BIOLOGICAL

Bacteria-based orally administered personalised neoantigen-targeting cancer vaccine

Also known as: Personalised neoantigen-targeting oral DNA 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).
• Male or female patients.
• Patients aged at least 18 years old at the time of ICF signature.
• Patients with solid tumors with measurable disease according to RECIST 1.1, planned to be treated with a PD-1 or PDL1 inhibitor as first- or second-line standard of care therapy according to national/institutional guidelines:
• Patients with tumor or metastasis accessible for guided needle biopsy or resection.
• Patients with adequate bone marrow function at Screening, confirmed at Baseline, including:
• absolute neutrophil count (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 × the upper limit of normal (ULN); patients treated with vitamin K antagonist are eligible if INR \<3 (at Screening and confirmed at Baseline).
• 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 estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using 2021 CKD-EPI creatinine equation (eGFR =142\*min(standardized Scr/K, 1)α\*max(standardized Scr/K, 1)-1.200 \*0.9938Age \*1.012 \[if female\] where K = 0.7 \[females\] or 0.9 \[males\], α = -0.241 \[females\] or -0.302 \[males\], min = indicates the minimum of Scr/K or 1, and max = indicates the maximum of Scr/K or 1).

You may not qualify if:

• Medical and surgical history, and diseases
• 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.
• Symptomatic brain metastasis.
• Any significant co-morbidity which, according to the Investigator's judgement, makes patient compliance to trial conditions unlikely.
• Previous malignant disease (other than the tumor disease for this trial) within the last 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 2 years prior to Screening, and the patient is deemed to have been cured with no additional therapy required or anticipated to be required.
• Prior organ transplantation, including allogeneic stem cell transplantation.
• Congenital or any other immunodeficiency syndromes, or any active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, except for:
• patients with vitiligo, psoriasis, alopecia not requiring immunosuppressive treatment, are eligible.
• administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation), which is acceptable.
• History of uncontrolled intercurrent illness, including but not limited to uncontrolled hypertension (high blood pressure despite of combination therapy with diuretic/CCB/ACE or ARB).
• Known prior hypersensitivity to the IMP 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).
• Persisting toxicity related to prior therapy (NCI CTCAE v5.0 Grade \>1); however, alopecia, sensory neuropathy Grade ≤2, or other Grade ≤2 AEs not constituting a safety risk based on Investigator's judgement are acceptable.
• Other severe acute or chronic medical conditions (if there is one of the medical conditions at baseline, the patient should not be treated), including
• immune colitis
• inflammatory bowel disease

Sponsors & Collaborators

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

Study Sites (8)

Charité

Berlin, Germany

Location

NCT

Heidelberg, Germany

Location

Comprehensive Cancer Center

Munich, Germany

Location

National Cancer Center

Vilnius, Lithuania

Location

Institut Catala d'Oncologia

Barcelona, Spain

Location

Vall d'Hebron

Barcelona, Spain

Location

Fundacion Jimenez Diaz

Madrid, Spain

Location

CHUS Santiago de Compostela

Santiago de Compostela, Spain

Location

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: October 7, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

ES (4); DE (3); LI (1)