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Solid TumorPhase 1/2NCT06631079

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

A Phase 1/2 study testing NECVAX-NEO1 in people with Solid Tumor, run by NEC Bio B.V at 8 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
NECVAX-NEO1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
8 sitesin 3 countries
Study dates
7 Oct 2024to 31 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • Patients must be able to undergo MRI or CT scan for tumor follow-up.
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Life expectancy of at least 6 months at the time of ICF signature, according to the Investigator's judgement at the time of ICF signature.

Who cannot join

  • 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.
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  • 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
  • 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.
  • History of small intestine resection surgery or other major gastrointestinal surgery
  • Active infection requiring systemic therapy with antibiotics (at both Screening and Baseline).
  • Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome or multi-drug resistant gram-negative bacteria.
  • 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.
  • 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).
  • Women who are pregnant or breastfeeding, or women of childbearing potential (defined as any woman who is not surgically sterile with a hysterectomy and/or bilateral oophorectomy or ≥ 12 moths of amenorrhea and at least 50 years of age) not willing to use highly effective methods of birth control up to 6 months after the last dose of IMP. Males of child-bearing potential not willing to use a highly effective method of birth control to avoid pregnancy with any partner during the study and until 90 days after the last dose of IMP
  • Known history of drug/substance abuse. Prior and concomitant medication
  • Live vaccines within 30 days prior to trial treatment.
  • Treatment in any other clinical trial medication within 30 days, before Screening.
  • Any other condition or treatment that, in the opinion of the Investigator, might interfere with the trial.
  • Current drug or substance abuse.
  • Chronic concurrent therapy within 2 weeks before the trial treatment or expected during the trial treatment period with:
  • corticosteroids (except systemic corticosteroids up to 10 mg prednisolone or equivalent daily dose [oral, intramuscular, or intravenous]).
  • immunosuppressive agents.
  • antibiotics.
  • any other anticancer therapy or concurrent anticancer treatment (except for other checkpoint inhibitors in combination with the anti-PD-1 or anti-PD-L1 monoclonal antibody), for example, cytoreductive therapy, radiotherapy with the exception of palliative short course, limited field (i.e., ≤10 fractions and ≤30% bone marrow involvement or per institutional standard) radiotherapy, which may be administered during the trial. However, IMP dosing must be suspended at least 14 days prior to the start of radiotherapy and must not be resumed until at least 14 days after the last radiotherapy fraction, cytokine therapy, except for erythropoietin.
  • Other
  • Inability to understand the Protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.
  • Unlikely to comply with the Protocol requirements, instructions, and trial-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial).
  • Legal incapacity or limited legal capacity.
  • Any condition which results in an undue risk for the patient during the trial participation according to the Investigator.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Spain4 sites

  • Institut Catala d'Oncologia

    Barcelona

  • Vall d'Hebron

    Barcelona

  • Fundacion Jimenez Diaz

    Madrid

  • CHUS Santiago de Compostela

    Santiago de Compostela

Other trials in Spain

Germany3 sites

  • Charité

    Berlin

  • NCT

    Heidelberg

  • Comprehensive Cancer Center

    Munich

Other trials in Germany

Lithuania1 site

  • National Cancer Center

    Vilnius

Other trials in Lithuania

About this study

Official title: An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients With Solid Tumors

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

Read the detailed description

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.

Personalised NECVAX-NEO1 is an oral, bacteria-based therapeutic vaccine that incorporates a sequence of patient-specific neoantigens selected by the NEC Immune Profiler. It is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to specifically recognize and destroy tumor cells based on the patient's own neoantigens. NECVAX-NEO1 will be manufactured as a patient-specific Investigational Medicinal Product (IMP) for add-on therapy to the SoC PD-1/PD-L1 inhibitor therapy.

For each patient, the trial will consist of:

  • Screening visit: To evaluate patients for inclusion in the trial. The patient signs the informed consent form (ICF), eligibility is confirmed, and a biopsy is taken to start manufacturing of the personalized NECVAX-NEO1.
  • Induction period. This is the SoC treatment period, during which treatment with PD-1/PD-L1 inhibitor therapy is started. This is approximately 8 to 12 weeks, depending on the type of PD-1/PD-L1 inhibitor used. The neoantigen selection and manufacturing of the personalized NECVAX-NEO1 takes place during the induction period.
  • Baseline visit. At this visit, when the personalized NECVAX-NEO1 treatment is available and the RECIST/iRECIST tumor assessment is performed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, eligibility will be re-confirmed, after which the patient will be assigned to either Cohort 1 (SD or PR according to RECIST 1.1) or Cohort 2 (PD according to RECIST 1.1).
  • Treatment period of up to 24 weeks which will mark the addition of new therapy to existing therapy, i.e., prime and booster administrations of NECVAX-NEO1 in addition to PD-1/PD-L1 inhibitor.
  • Post-treatment Follow-up period of 4 weeks, with an End of Treatment (EoT) visit at Week 28.
  • After the EoT (Week 28), a Long-Term Safety Monitoring Period, following the administration of a genetically modified organism, will occur for up to 24 months.
Conditions
Solid Tumor
Being tested
NECVAX-NEO1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NECVAX-NEO1Biological

    Also called Personalised neoantigen-targeting oral DNA cancer vaccine

    Bacteria-based orally administered personalised neoantigen-targeting cancer vaccine

Study groups in NCT06631079
Study groupRoleWhat they receive
NECVAX-NEO1ExperimentalOral DNA Vaccine
Receives: Biological: NECVAX-NEO1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to week 24 plus 24 months

  2. 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)

    Measured: Up to week 24 plus 24 months

  3. Change from Baseline in Laboratory Parameters

    Laboratory Parameter Units

    Measured: Up to week 24 plus 24 months

  4. Change from Baseline in Electrocardiograms

    ECG QT interval

    Measured: Up to 24 weeks plus 24 months

Secondary outcomes (5)

  1. Antitumor activity

    Changes in ctDNA

    Measured: Up to 24 weeks

  2. Objective Response Rate

    Proportion of patients having a best overall response (BOR) of complete response (CR) or partial response (PR) relative to baseline or screening visit

    Measured: Up to Week 24 plus 24 months

  3. Progression free survival

    Time from first NECVAX-NEO1 administration to the first of progressive disease (PD) or death

    Measured: Up to 24 weeks plus 24 months

  4. Time to progression

    Time from first NECVAX-NEO1 administration to PD

    Measured: Up to 24 weeks plus 24 months

  5. Overall survival

    Time from first NECVAX-NEO1 administration to death

    Measured: Up to 24 weeks plus 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start7 Oct 2024
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06631079
Sponsor's protocol ID
NECVAX-NEO1-02-INT
Status last verified
Jan 2026
First submitted
2 Oct 2024
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NECVAX-NEO1 in people with Solid Tumor, run by NEC Bio B.V at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain, Germany, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Up to week 24 plus 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06631079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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